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A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNFα Naive Participants With Active Radiographic Axial Spondyloarthritis

Primary Purpose

Axial Spondyloarthritis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Ustekinumab 45 mg
Ustekinumab 90 mg
Golimumab 50 mg
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Axial Spondyloarthritis focused on measuring Axial Spondyloarthritis, Ustekinumab, Golimumab, Stelara

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants must have a diagnosis of definite ankylosing spondylitis (AS), as defined by the modified 1984 New York criteria. The radiographic criterion must be confirmed by a central xray reader and at least 1 clinical criterion must be met
  • Participants must have symptoms of active disease at screening and at baseline, as evidenced by both a BASDAI score of greater than or equal to (>=4) and a visual analog scale (VAS) score for total back pain of >=4, each on a scale of 0 to 10
  • Participants with elevated high sensitivity C-reactive protein (hsCRP) level of >=0.300 milligram per deciliter (mg/dL) at Screening
  • If using nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesics for AS, must be on a stable dose for at least 2 weeks prior to the first administration of study agent. If currently not using NSAIDs or other analgesics for AS, must not have received NSAIDs or other analgesics for AS for at least 2 weeks prior to the first administration of the study agent
  • A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test at Week 0 before randomization

Exclusion Criteria:

  • Participants who have other inflammatory diseases that might confound the evaluations of benefit from the ustekinumab therapy, including but not limited to, rheumatoid arthritis, systemic lupus erythematosus, or Lyme disease
  • Participants who are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in the study or within 5 months after receiving the last administration of study agent
  • Participants who have received any prior biologic therapy, including but not limited to anti-TNF alpha agents, tocilizumab, alefacept, efalizumab, natalizumab, abatacept, anakinra, ustekinumab, tidrakizumab or other anti-interleukin (IL) 23 biologics, brodalumab, secukinumab, ixekizumab, and B-cell depleting therapies
  • Participants who have received any systemic immunosuppressives or disease-modifying antirheumatic drugs (DMARDs) other than methotrexate (MTX), sulfasalazine (SSZ), or hydroxychloroquine (HCQ) within 4 weeks prior to first administration of study agent. Medications in these categories include, but are not limited to chloroquine, azathioprine, cyclosporine, mycophenolate mofetil, gold, and penicillamine
  • Participant who have received leflunomide within 3 months prior to the first administration of study agent (irrespective of undergoing a drug elimination procedure), or have received leflunomide within 12 months prior to the first administration of study agent and have not undergone a drug elimination procedure

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Group 1 (Placebo)

Group 2 (Ustekinumab 45 mg)

Group 3 (Ustekinumab 90 mg)

Arm Description

Placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) will be re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 100. Participants who meet EE criteria (less than [<] 10 percent [%] improvement from baseline in both total back pain and morning stiffness measures at both Week 12 and Week 16) will be administered open-label golimumab 50 mg SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52.

Ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing, with the last administration of study agent at Week 100. At Week 24, participants will receive placebo SC injection to maintain the blind. Participants who meet EE criteria (<10% improvement from baseline in both total back pain and morning stiffness measures at both Week 12 and Week 16) will be administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52.

Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 100. At Week 24, participants will receive placebo SC injection to maintain the blind. Participants who meet EE criteria (<10% improvement from baseline in both total back pain and morning stiffness measures at both Week 12 and Week 16) will be administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52.

Outcomes

Primary Outcome Measures

Percentage of Participants Who Achieved an Assessment of Spondyloarthritis International Society (ASAS) 40 Response at Week 24
ASAS 40 defined as improvement from baseline of greater than or equal to (>=) 40 percent (%) and absolute improvement from baseline of at least 2 on 0 to 10 centimeter (cm) scale in at least 3 of following 4 domains: Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation(0 to 10cm;0=none,10=very severe); no worsening at all from baseline in remaining domain. ASAS40 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).

Secondary Outcome Measures

Percentage of Participants Who Achieved an Assessment of Spondyloarthritis International Society (ASAS) 20 Response at Week 24
ASAS 20 defined as improvement from baseline of >= 20% and with an absolute improvement from baseline of 1 on a 0 to 10cm scale in at least 3 of following 4 domains:Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain(0 to 10cm; 0=no pain,10=most severe pain),Bath Ankylosing Spondylitis Functional Index (BASFI) (self-assessment represented as mean(0 to 10 cm; 0=easy to 10=impossible) of 10 questions,8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life, Inflammation (0 to 10cm;0=none,10=very severe);absence of deterioration from baseline(>= 20% and worsening of at least 1 on a 0 to 10 cm scale) in the potential remaining domain. ASAS 20 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).
Percentage of Participants Who Achieved at Least a 50 Percent (%) Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24
BASDAI used to measure ankylosing spondylitis (AS) disease severity. Consists of 6 questions: fatigue,spinal pain,arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons, ligaments),morning stiffness(MS) (2 questions:duration, severity). Each question is easy to answer 10cm VAS, 0(none),10(very severe) and for the last question related to morning stiffness duration: 0(0 hours), 10(2 or more hours). In order to give each 5 symptoms equal weight, mean of 2 questions about MS added to total of remaining 4 scores,final BASDAI score(ranging 0-10) is average of overall total score. Higher BASDAI indicates more severe AS symptom. 50% improvement from baseline based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rule(consider non-responder at W20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Week 24
The BASFI is composed with 10 questions (each question is answered with a visual analogue scale 0-10 cm) to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities of AS participants. Each question is a 10cm VAS with a value between 0 (easy) and 10 (impossible). The final BASFI score is the mean of the 10 scores. The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10. Higher BASFI score indicates more severe functional limitations of the participant due to AS. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score-C Reactive Protein (ASDAS-CRP) Inactive Disease (<1.3) at Week 24
ASDAS includes CRP milligram per liter(mg/L); four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included are total back pain (TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment(PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121*TBP) + (0.110*participant global) + (0.073*peripheral pain/swelling) + (0.058* DMS) + (0.579*Ln(CRP+1). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 [normal] to 10 [very severe]) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =>2 hours). Inactive disease is defined as an ASDAS score <1.3. ASDAS (CRP) Inactive Disease is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non-responder).
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24
Change from baseline in hsCRP levels were reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. Early escape rule was applied(measurement value at Week 20 and Week 24 was set as missing).
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) Total Score at Week 16 and 24
Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Entheses were scored as either 0 (nontender) or 1 (tender) yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness). Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 16 and 24
The Bath Ankylosing Spondylitis Metrology Index linear function is a combined index of 5 clinical measurements (performed by the Joint Assessor) which reflect axial mobility in the AS patient. The measurements to assess mobility are: 1)Tragus-to-wall; 2)Modified Schober (lumbar flexion); 3)Cervical rotation angle; 4)Lateral spinal flexion; 5)Intermalleolar distance. The BASMI linear result is the average of the 5 assessments and ranges from 0 to 10. The higher the BASMI score the more severe the patient's limitation of movement due to their AS. Early escape rule was applied (measurement value was set as missing).
Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) Score at Week 16 and 24
The ASQoL is a self-administered health-related quality of life (HRQOL) instrument. It consists of 18 items requesting a Yes or No response to questions related to the impact of the disease/condition (including pain) on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. A score of 1 is given to a response of "yes" on each item and all item scores are summed to a total score with a range of 0 to 18. Higher scores indicate worse HRQOL. Early escape rule was applied (measurement value was set as missing).
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 16 and 24
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score). Early escape rule was applied (measurement value was set as missing).
Change From Baseline in Short Form-(SF)-36 Physical Component Summary (PCS) and SF-36 Mental Component Summary (MCS) at Week 16 and 24
The Medical Outcome Study health measure SF-36 questionnaire is a well-validated and widely used quality-of-life instrument. It is a self-administered survey that consists of 8 multi-item scales: The 4 subscales of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and the 4 subscales of the SF-36 comprises the MCS score(vitality, social functioning, role-emotional, and mental health). PCS and MCS are scored from 0 to 100 with higher scores indicating better health (worst value is 0 and best value is 100), which are scored using a norm-based system where linear transformations are performed to transform scores to a mean of 50 and standard deviation of 10. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).
Change From Baseline in BASDAI Inflammation Score Through Week 24
The BASDAI is used to measure the ankylosing spondylitis (AS) disease severity. It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), and morning stiffness (2 questions: duration, severity). Each question is an easy to answer 10 centimeter (cm) visual analog scale (VAS), with 0 being none, and 10 being very severe and for the last question relating to morning stiffness duration: 0(0 hours), 10(2 or more hours). Change from baseline in inflammation was assessed by calculating the average of the Last 2 Questions of the BASDAI Concerning Morning Stiffness. Early escape rule was applied (measurement value was set as missing).
Change From Baseline in Composite and Domain Scores of Medical Outcomes Study Sleep Scale (MOS-SS) at Week 16 and 24
Sleep problems were assessed using the 12-item MOS-SS, a generic instrument designed to assess six dimensions of sleep: Sleep disturbance, Somnolence, Sleep adequacy, Snoring, Awaken short of breath or headache, and Quantity of sleep(QS)/optimal sleep(OS) during the past 4 weeks. The six dimensions were also used to generate the composite Sleep Problems Index (SPI). An increase in score from baseline represents improvement. Sleep disturbance, snoring, somnolence, awaken short of breath, sleep problems index have score ranges from 0(no sleep problems) to 100 (greater sleep problems), negative change indicates improvement. Sleep adequacy scored 0 (least sleep adequacy) to 100 (better sleep adequacy), positive change indicates improvement. Quantity of sleep is scored 0 (less quantity of sleep) to 24 (greater quantity of sleep), positive change indicates improvement. Early escape rule was applied (measurement value was set as missing).
Change From Baseline in Composite and Domain Scores of Medical Outcomes Study Sleep Scale (MOS-SS)-Quantity of Sleep/Optimal Sleep at Week 16 and 24
Sleep problems were assessed using the 12-item MOS-SS, a generic instrument designed to assess six dimensions of sleep: Sleep disturbance, Somnolence, Sleep adequacy, Snoring, Awaken short of breath or headache, QS/OS during past W4. 6 dimensions used to generate composite SPI. Increase in score from baseline represents improvement. Sleep adequacy scored 0 (least sleep adequacy[SA]) to 100 (better SA), positive change indicates improvement. QS is scored 0 (less QS) to 24 (greater QS), positive change indicates improvement. Single-item QS asks participants to estimate average number of hours they slept each night during past 4W (0-24 hours) and transformed into dichotomous OS Score, reported 7 (or 8) hours of sleep considered Optimal. OS is scored Yes if average hours of sleep is in range of 7-8 hours. Early escape rule was applied (measurement value was set as missing).
Percentage of Participants With at Least a 40% Improvement From Baseline in ASAS 40 Components at Week 24
ASAS 40 components included Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10cm;0=none,10=very severe). Percentage of Participants With at least a 40% improvement from baseline in each of the ASAS components was calculated.
Percentage of Participants Who Achieved at Least 20%, 50%, 70% and 90% Improvement From Baseline in BASDAI Through Week 24
BASDAI used to measure the AS disease severity. It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), and morning stiffness (2 questions: duration and severity). Each question is an easy to answer cm VAS with 0 being none, and 10 being very severe and for the last question relating to morning stiffness duration: 0(0 hours), 10(2 or more hours). In order to give each of the 5 symptoms equal weight, mean of 2 questions about morning stiffness will be added to total of remaining 4 scores, final BASDAI score (ranging 0-10) is average of overall total score. Higher BASDAI score indicates more severe AS symptom. 20 %,50%, 70%,90% improvement from baseline in BASDAI based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non-responders).
Change From Baseline in BASDAI Total Score Through Week 24
The BASDAI is used to measure the ankylosing spondylitis (AS) disease severity. It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), and morning stiffness (2 questions: duration and severity). Each question is an easy to answer 10 centimeter (cm) visual analog scale (VAS), with 0 being none, and 10 being very severe and for the last question relating to morning stiffness duration: 0(0 hours), 10(2 or more hours). In order to give each of the 5 symptoms equal weight, the mean of the 2 questions about morning stiffness will be added to the total of the remaining 4 scores, and the final BASDAI score (ranging 0-10) is the average of the overall total score. Higher BASDAI score indicates more severe AS symptom. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).
Percentage of Participants Who Achieved ASAS 40 Response at Week 4, 8, 12, 16 and 20
ASAS 40 defined as improvement from baseline of greater than or equal to (>=) 40% and with an absolute improvement from baseline of at least 2 on 0 to10cm scale in at least 3 of following 4 domains: Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10cm;0=none,10=very severe); no worsening at all from baseline in remaining domain. ASAS40 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).
Percentage of Participants Who Achieved ASAS 20 Response at Week 4, 8, 12, 16 and 20
ASAS 20 defined as improvement from baseline of greater than or equal to (>=) 20% and with an absolute improvement from baseline of 1 on a 0 to 10 cm scale in at least 3 of following 4 domains: Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10cm;0=none,10=very severe); absence of deterioration (>= 20% and worsening of at least 1 on a 0 to 10 cm scale) from baseline in the potential remaining domain. ASAS20 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).
Percentage of Participants Who Achieved Assessment of Spondyloarthritis International Society (ASAS) Partial Remission Through Week 24
Low level of disease activity was measured by criteria for ASAS partial remission, defined as a value below 2 on a scale of 0 to 10 cm in each of the 4 ASAS domains: patient's global assessment of disease activity, total back pain, function (BASFI), inflammation. ASAS partial remission response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).
Percentage of Participants Who Achieved ASAS 5/6 Response at Week 16 and 24
ASAS 5/6 is defined as a >=20% improvement in any 5 of the 6 domains of pain (VAS 0 to 10), patient global (VAS 0 to 10), function (BASFI score), morning stiffness (from BASDAI), hsCRP, and spine mobility (lumbar side flexion). ASAS 5/6 response is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).
Change From Baseline in Ankylosing Spondylitis Disease Activity Score ASDAS (CRP) Total Score Through Week 24
ASDAS includes CRP mg/L; 4 additional self-reported items (rated 0-10cm VAS or 0-10 numerical rating scale [NRS]) included are total back pain (TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment (PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121*TBP)+(0.110*PGA) + (0.073*peripheral pain(PP)/swelling)+(0.058* duration of morning stiffness)+(0.579*Ln(CRP+1)). The disease activity, TBP, and PP/swelling on a NRS(0[normal]-10[very severe]and DMS on NRS(0 to 10, 0 being none and 10 representing a duration=>2 hours). The scores were categorized as: inactive disease (< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity (> 3.5). The calculated score can be from 0 to no defined upper limit. A negative number indicates a reduction in the score which indicates decrease in disease activity. Early escape rule was applied (measurement value was set as missing).
Percentage of Participants Who Achieved ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16 and 20
ASDAS includes CRP mg/L; four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included are total back pain (TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment (PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121*total back pain) + (0.110*participant global) + (0.073*peripheral pain/swelling) + (0.058* duration of morning stiffness) + (0.579*Ln(CRP+1)). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =>2 hours). Inactive disease is defined as an ASDAS score <1.3. ASDAS (CRP) Inactive Disease is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non- responders).
Percentage of Participants With ASDAS (CRP) Major Improvement (Decrease >=2.0) Through Week 24
ASDAS includes CRP mg/L; four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included are total back pain (TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment (PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121*TBP) + (0.110*participant global) + (0.073*peripheral pain/swelling) + (0.058* DMS) + (0.579*Ln(CRP+1)). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =>2 hours). Major improvement in ASDAS is defined as a decrease from baseline >=2.0. ASDAS (CRP) major improvement (decrease >=2.0) is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non- responders).
Percentage of Participants Who Achieved ASDAS (CRP) Clinically Important Improvement (Decrease >=1.1) Through Week 24
ASDAS includes CRP mg/L; four additional self-reported items (rated on 0-10cm VAS or 0-10 NRS) included are TBP, duration of DMS, peripheral pain/swelling and patient global assessment (PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121*TBP) + (0.110*participant global) + (0.073*peripheral pain/swelling) + (0.058*DMS) + (0.579*Ln(CRP+1)). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =>2 hours). Clinically important improvement in ASDAS is defined as a decrease from baseline >=1.1. ASDAS (CRP) clinical important improvement (decrease >=1.1) is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non- responders).
Change From Baseline in BASFI at Week 4, 8, 12, 16 and 20
The BASFI is composed with 10 questions (each question is answered with a visual analogue scale 0-10 cm) to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities of AS participants. Each question is a 10cm VAS with a value between 0 (easy) and 10 (impossible). The final BASFI score is the mean of the 10 scores. The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10. Higher BASFI score indicates more severe functional limitations of the participant due to AS. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).
Change From Baseline in Chest Expansion at Week 16 and 24
Chest expansion is the difference, in centimeter (cm), between the circumference of the chest in maximal inspiration and maximal expiration. It is measured at the level of the fourth intercostal space in males, and just below the breasts in females. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).
Change From Baseline in Total Back Pain (TBP) and Night Back Pain (NBP) Through Week 24
The total back pain and nighttime back pain was measured on a VAS (0 to 10 cm; 0 = no pain, 10 = most severe pain). Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).
Change From Baseline in Patients Global Assessment of Disease Activity Through Week 24
Participants assessed their disease activity using a 10 cm visual analog scale, with responses ranging from 0 (very well) to 10 (very poor). Early escape rule was applied (The measurement value at Week 20 and Week 24 was set as missing).
Change From Baseline in European Quality of Life 5 Dimension (EQ-5D) Visual Analog Scale (VAS) Score at Week 16 and 24
The EQ-5D questionnaire is a brief, generic health-related quality of life assessment (HRQOL) that can also be used to incorporate participant preferences into health economic evaluations. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).
Change From Baseline in EQ-5D Index Score at Week 16 and 24
The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing death. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).
Change From Baseline in Berlin Magnetic Resonance Imaging (MRI) Spine Score at Week 24
The study used MRI with fat-saturating techniques such as short tau inversion recovery (STIR) to look for the presence of bone marrow edema. The Berlin modification of Ankylosing Spondylitis spine MRI score for activity (ASspiMRI-a) scoring technique assesses inflammation in each of the 23 disc vertebral units (DVU), capturing edema and erosion. Scores for each DVU range from 0-3 (0=normal; 1=minor bone marrow edema [less than or equal to 25% of DVU; 3=severe bone marrow edema (more that 50% of DVU)]. The composite score ranges from 0 to 69, with higher scores indicating more severe inflammation.
Change From Baseline in Percent Work Time Missed Due to AS (Assessed by Work Productivity and Activity Impairment Questionnaire - Specific Health Problem [WPAI-SHP]) Through Week 24
The WPAI-SHP is a 6-item questionnaire used to assess the degree to which a specified health problem (here "AS") affected work attendance, work productivity and productivity in non-work regular activities. Patients are asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity. change from baseline in percent work time missed due to AS for each study arm are reported.
Change From Baseline in Percent Impairment While Working Due to AS (Assessed by WPAI-SHP) Through Week 24
WPAI-SHP is 6-item questionnaire used to assess the degree to which a specified health problem ("AS") affected work attendance, work productivity and productivity in non-work regular activities. Patients are asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity. change from baseline in percent impairment while working due to AS for each study arm are reported.
Change From Baseline in Percent Overall Work Impairment Due to AS (Assessed by WPAI-SHP) Through Week 24
WPAI-SHP is 6-item questionnaire used to assess the degree to which a specified health problem (AS) affected work attendance, work productivity and productivity in non-work regular activities. Patients are asked to consider the past 7 days prior to each questionnaire day. Questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity. change from baseline in percent overall work impairment due to AS for each study arm are reported.
Change From Baseline in Percent Non-work Activity Impairment Due to AS (Assessed by WPAI-SHP) Through Week 24
WPAI-SHP is6-item questionnaire used to assess the degree to which a specified health problem (AS) affected work attendance, work productivity and productivity in non-work regular activities. Patients are asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity. change from baseline in percent non-work activity impairment due to AS for each study arm are reported.

Full Information

First Posted
May 5, 2015
Last Updated
August 26, 2019
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02437162
Brief Title
A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNFα Naive Participants With Active Radiographic Axial Spondyloarthritis
Official Title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF Alpha Naive Subjects With Active Radiographic Axial Spondyloarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
Neither dose achieved the study's primary or major secondary endpoints. The safety profile was consistent with previous ustekinumab studies.
Study Start Date
September 3, 2015 (Actual)
Primary Completion Date
March 22, 2017 (Actual)
Study Completion Date
September 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the efficacy of ustekinumab, in adult participants with active radiographic axial spondyloarthritis (AxSpA), who are naive to anti-TNF alpha agents, as measured by the reduction in signs and symptoms of radiographic AxSpA.
Detailed Description
This is a Phase 3, multicenter (when more than one hospital or medical school team work on a medical research study), randomized (study medication assigned to participants by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect) study. The study consists of 3 phases; Screening (up to 8 weeks), Treatment phase: placebo-controlled (Week 0 to 24) and active treatment (Week 24 to Week 100), and Safety Follow-up (12 weeks after last dose). Participants will be randomly assigned to 1 of 3 treatment groups: placebo, ustekinumab 45 mg and ustekinumab 90 mg. The total duration of study will be up to 112 weeks. Participants will be primarily assessed for Assessment of SpondyloArthritis International Society (ASAS) 40 response at Week 24. Participants' safety will be monitored throughout the trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Axial Spondyloarthritis
Keywords
Axial Spondyloarthritis, Ustekinumab, Golimumab, Stelara

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
347 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (Placebo)
Arm Type
Placebo Comparator
Arm Description
Placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) will be re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 100. Participants who meet EE criteria (less than [<] 10 percent [%] improvement from baseline in both total back pain and morning stiffness measures at both Week 12 and Week 16) will be administered open-label golimumab 50 mg SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52.
Arm Title
Group 2 (Ustekinumab 45 mg)
Arm Type
Experimental
Arm Description
Ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing, with the last administration of study agent at Week 100. At Week 24, participants will receive placebo SC injection to maintain the blind. Participants who meet EE criteria (<10% improvement from baseline in both total back pain and morning stiffness measures at both Week 12 and Week 16) will be administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52.
Arm Title
Group 3 (Ustekinumab 90 mg)
Arm Type
Experimental
Arm Description
Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 100. At Week 24, participants will receive placebo SC injection to maintain the blind. Participants who meet EE criteria (<10% improvement from baseline in both total back pain and morning stiffness measures at both Week 12 and Week 16) will be administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive Placebo subcutaneous (SC) injection at Weeks 0, 4, and 16 in Group 1 and at Week 24 in Group 2 and Group 3.
Intervention Type
Drug
Intervention Name(s)
Ustekinumab 45 mg
Intervention Description
Participants will receive Ustekinumab 45 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 100 in Group 1. Participants will start with ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 100 in Group 2.
Intervention Type
Drug
Intervention Name(s)
Ustekinumab 90 mg
Intervention Description
Participants will receive Ustekinumab 90 mg SC injection at Weeks 24 and 28 followed by q12w dosing, with the last administration of study agent at Week 100 in Group 1. Participants will start with ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 100 in Group 3.
Intervention Type
Drug
Intervention Name(s)
Golimumab 50 mg
Intervention Description
Participants who meet EE criteria (less than [<] 10 percent [%] improvement from baseline in both total back pain and morning stiffness measures at both Week 12 and Week 16) will be administered open-label golimumab 50 mg SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52 in Groups 1, 2 and 3.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Achieved an Assessment of Spondyloarthritis International Society (ASAS) 40 Response at Week 24
Description
ASAS 40 defined as improvement from baseline of greater than or equal to (>=) 40 percent (%) and absolute improvement from baseline of at least 2 on 0 to 10 centimeter (cm) scale in at least 3 of following 4 domains: Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation(0 to 10cm;0=none,10=very severe); no worsening at all from baseline in remaining domain. ASAS40 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieved an Assessment of Spondyloarthritis International Society (ASAS) 20 Response at Week 24
Description
ASAS 20 defined as improvement from baseline of >= 20% and with an absolute improvement from baseline of 1 on a 0 to 10cm scale in at least 3 of following 4 domains:Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain(0 to 10cm; 0=no pain,10=most severe pain),Bath Ankylosing Spondylitis Functional Index (BASFI) (self-assessment represented as mean(0 to 10 cm; 0=easy to 10=impossible) of 10 questions,8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life, Inflammation (0 to 10cm;0=none,10=very severe);absence of deterioration from baseline(>= 20% and worsening of at least 1 on a 0 to 10 cm scale) in the potential remaining domain. ASAS 20 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).
Time Frame
Week 24
Title
Percentage of Participants Who Achieved at Least a 50 Percent (%) Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24
Description
BASDAI used to measure ankylosing spondylitis (AS) disease severity. Consists of 6 questions: fatigue,spinal pain,arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons, ligaments),morning stiffness(MS) (2 questions:duration, severity). Each question is easy to answer 10cm VAS, 0(none),10(very severe) and for the last question related to morning stiffness duration: 0(0 hours), 10(2 or more hours). In order to give each 5 symptoms equal weight, mean of 2 questions about MS added to total of remaining 4 scores,final BASDAI score(ranging 0-10) is average of overall total score. Higher BASDAI indicates more severe AS symptom. 50% improvement from baseline based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rule(consider non-responder at W20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).
Time Frame
Week 24
Title
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Week 24
Description
The BASFI is composed with 10 questions (each question is answered with a visual analogue scale 0-10 cm) to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities of AS participants. Each question is a 10cm VAS with a value between 0 (easy) and 10 (impossible). The final BASFI score is the mean of the 10 scores. The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10. Higher BASFI score indicates more severe functional limitations of the participant due to AS. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).
Time Frame
Baseline and Week 24
Title
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score-C Reactive Protein (ASDAS-CRP) Inactive Disease (<1.3) at Week 24
Description
ASDAS includes CRP milligram per liter(mg/L); four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included are total back pain (TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment(PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121*TBP) + (0.110*participant global) + (0.073*peripheral pain/swelling) + (0.058* DMS) + (0.579*Ln(CRP+1). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 [normal] to 10 [very severe]) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =>2 hours). Inactive disease is defined as an ASDAS score <1.3. ASDAS (CRP) Inactive Disease is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non-responder).
Time Frame
Week 24
Title
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24
Description
Change from baseline in hsCRP levels were reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. Early escape rule was applied(measurement value at Week 20 and Week 24 was set as missing).
Time Frame
Baseline, Week 4, 8, 12, 16, 20 and 24
Title
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) Total Score at Week 16 and 24
Description
Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Entheses were scored as either 0 (nontender) or 1 (tender) yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness). Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).
Time Frame
Baseline, Week 16 and 24
Title
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 16 and 24
Description
The Bath Ankylosing Spondylitis Metrology Index linear function is a combined index of 5 clinical measurements (performed by the Joint Assessor) which reflect axial mobility in the AS patient. The measurements to assess mobility are: 1)Tragus-to-wall; 2)Modified Schober (lumbar flexion); 3)Cervical rotation angle; 4)Lateral spinal flexion; 5)Intermalleolar distance. The BASMI linear result is the average of the 5 assessments and ranges from 0 to 10. The higher the BASMI score the more severe the patient's limitation of movement due to their AS. Early escape rule was applied (measurement value was set as missing).
Time Frame
Baseline, Week 16 and 24
Title
Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) Score at Week 16 and 24
Description
The ASQoL is a self-administered health-related quality of life (HRQOL) instrument. It consists of 18 items requesting a Yes or No response to questions related to the impact of the disease/condition (including pain) on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. A score of 1 is given to a response of "yes" on each item and all item scores are summed to a total score with a range of 0 to 18. Higher scores indicate worse HRQOL. Early escape rule was applied (measurement value was set as missing).
Time Frame
Baseline, Week 16 and 24
Title
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 16 and 24
Description
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score). Early escape rule was applied (measurement value was set as missing).
Time Frame
Baseline, Week 16 and 24
Title
Change From Baseline in Short Form-(SF)-36 Physical Component Summary (PCS) and SF-36 Mental Component Summary (MCS) at Week 16 and 24
Description
The Medical Outcome Study health measure SF-36 questionnaire is a well-validated and widely used quality-of-life instrument. It is a self-administered survey that consists of 8 multi-item scales: The 4 subscales of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and the 4 subscales of the SF-36 comprises the MCS score(vitality, social functioning, role-emotional, and mental health). PCS and MCS are scored from 0 to 100 with higher scores indicating better health (worst value is 0 and best value is 100), which are scored using a norm-based system where linear transformations are performed to transform scores to a mean of 50 and standard deviation of 10. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).
Time Frame
Baseline, Week 16 and 24
Title
Change From Baseline in BASDAI Inflammation Score Through Week 24
Description
The BASDAI is used to measure the ankylosing spondylitis (AS) disease severity. It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), and morning stiffness (2 questions: duration, severity). Each question is an easy to answer 10 centimeter (cm) visual analog scale (VAS), with 0 being none, and 10 being very severe and for the last question relating to morning stiffness duration: 0(0 hours), 10(2 or more hours). Change from baseline in inflammation was assessed by calculating the average of the Last 2 Questions of the BASDAI Concerning Morning Stiffness. Early escape rule was applied (measurement value was set as missing).
Time Frame
Baseline, Week 4, 8, 12, 16, 20 and 24
Title
Change From Baseline in Composite and Domain Scores of Medical Outcomes Study Sleep Scale (MOS-SS) at Week 16 and 24
Description
Sleep problems were assessed using the 12-item MOS-SS, a generic instrument designed to assess six dimensions of sleep: Sleep disturbance, Somnolence, Sleep adequacy, Snoring, Awaken short of breath or headache, and Quantity of sleep(QS)/optimal sleep(OS) during the past 4 weeks. The six dimensions were also used to generate the composite Sleep Problems Index (SPI). An increase in score from baseline represents improvement. Sleep disturbance, snoring, somnolence, awaken short of breath, sleep problems index have score ranges from 0(no sleep problems) to 100 (greater sleep problems), negative change indicates improvement. Sleep adequacy scored 0 (least sleep adequacy) to 100 (better sleep adequacy), positive change indicates improvement. Quantity of sleep is scored 0 (less quantity of sleep) to 24 (greater quantity of sleep), positive change indicates improvement. Early escape rule was applied (measurement value was set as missing).
Time Frame
Baseline, Week (W) 16 and 24
Title
Change From Baseline in Composite and Domain Scores of Medical Outcomes Study Sleep Scale (MOS-SS)-Quantity of Sleep/Optimal Sleep at Week 16 and 24
Description
Sleep problems were assessed using the 12-item MOS-SS, a generic instrument designed to assess six dimensions of sleep: Sleep disturbance, Somnolence, Sleep adequacy, Snoring, Awaken short of breath or headache, QS/OS during past W4. 6 dimensions used to generate composite SPI. Increase in score from baseline represents improvement. Sleep adequacy scored 0 (least sleep adequacy[SA]) to 100 (better SA), positive change indicates improvement. QS is scored 0 (less QS) to 24 (greater QS), positive change indicates improvement. Single-item QS asks participants to estimate average number of hours they slept each night during past 4W (0-24 hours) and transformed into dichotomous OS Score, reported 7 (or 8) hours of sleep considered Optimal. OS is scored Yes if average hours of sleep is in range of 7-8 hours. Early escape rule was applied (measurement value was set as missing).
Time Frame
Baseline, Week (W) 16 and 24
Title
Percentage of Participants With at Least a 40% Improvement From Baseline in ASAS 40 Components at Week 24
Description
ASAS 40 components included Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10cm;0=none,10=very severe). Percentage of Participants With at least a 40% improvement from baseline in each of the ASAS components was calculated.
Time Frame
Week 24
Title
Percentage of Participants Who Achieved at Least 20%, 50%, 70% and 90% Improvement From Baseline in BASDAI Through Week 24
Description
BASDAI used to measure the AS disease severity. It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), and morning stiffness (2 questions: duration and severity). Each question is an easy to answer cm VAS with 0 being none, and 10 being very severe and for the last question relating to morning stiffness duration: 0(0 hours), 10(2 or more hours). In order to give each of the 5 symptoms equal weight, mean of 2 questions about morning stiffness will be added to total of remaining 4 scores, final BASDAI score (ranging 0-10) is average of overall total score. Higher BASDAI score indicates more severe AS symptom. 20 %,50%, 70%,90% improvement from baseline in BASDAI based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non-responders).
Time Frame
Baseline, Week 4, 8, 12, 16, 20 and 24
Title
Change From Baseline in BASDAI Total Score Through Week 24
Description
The BASDAI is used to measure the ankylosing spondylitis (AS) disease severity. It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), and morning stiffness (2 questions: duration and severity). Each question is an easy to answer 10 centimeter (cm) visual analog scale (VAS), with 0 being none, and 10 being very severe and for the last question relating to morning stiffness duration: 0(0 hours), 10(2 or more hours). In order to give each of the 5 symptoms equal weight, the mean of the 2 questions about morning stiffness will be added to the total of the remaining 4 scores, and the final BASDAI score (ranging 0-10) is the average of the overall total score. Higher BASDAI score indicates more severe AS symptom. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).
Time Frame
Baseline, Week 4, 8, 12, 16, 20 and 24
Title
Percentage of Participants Who Achieved ASAS 40 Response at Week 4, 8, 12, 16 and 20
Description
ASAS 40 defined as improvement from baseline of greater than or equal to (>=) 40% and with an absolute improvement from baseline of at least 2 on 0 to10cm scale in at least 3 of following 4 domains: Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10cm;0=none,10=very severe); no worsening at all from baseline in remaining domain. ASAS40 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).
Time Frame
Week 4, 8, 12, 16 and 20
Title
Percentage of Participants Who Achieved ASAS 20 Response at Week 4, 8, 12, 16 and 20
Description
ASAS 20 defined as improvement from baseline of greater than or equal to (>=) 20% and with an absolute improvement from baseline of 1 on a 0 to 10 cm scale in at least 3 of following 4 domains: Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10cm;0=none,10=very severe); absence of deterioration (>= 20% and worsening of at least 1 on a 0 to 10 cm scale) from baseline in the potential remaining domain. ASAS20 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).
Time Frame
Week 4, 8, 12, 16 and 20
Title
Percentage of Participants Who Achieved Assessment of Spondyloarthritis International Society (ASAS) Partial Remission Through Week 24
Description
Low level of disease activity was measured by criteria for ASAS partial remission, defined as a value below 2 on a scale of 0 to 10 cm in each of the 4 ASAS domains: patient's global assessment of disease activity, total back pain, function (BASFI), inflammation. ASAS partial remission response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).
Time Frame
Baseline, Week 4, 8, 12, 16, 20 and 24
Title
Percentage of Participants Who Achieved ASAS 5/6 Response at Week 16 and 24
Description
ASAS 5/6 is defined as a >=20% improvement in any 5 of the 6 domains of pain (VAS 0 to 10), patient global (VAS 0 to 10), function (BASFI score), morning stiffness (from BASDAI), hsCRP, and spine mobility (lumbar side flexion). ASAS 5/6 response is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).
Time Frame
Week 16 and 24
Title
Change From Baseline in Ankylosing Spondylitis Disease Activity Score ASDAS (CRP) Total Score Through Week 24
Description
ASDAS includes CRP mg/L; 4 additional self-reported items (rated 0-10cm VAS or 0-10 numerical rating scale [NRS]) included are total back pain (TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment (PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121*TBP)+(0.110*PGA) + (0.073*peripheral pain(PP)/swelling)+(0.058* duration of morning stiffness)+(0.579*Ln(CRP+1)). The disease activity, TBP, and PP/swelling on a NRS(0[normal]-10[very severe]and DMS on NRS(0 to 10, 0 being none and 10 representing a duration=>2 hours). The scores were categorized as: inactive disease (< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity (> 3.5). The calculated score can be from 0 to no defined upper limit. A negative number indicates a reduction in the score which indicates decrease in disease activity. Early escape rule was applied (measurement value was set as missing).
Time Frame
Baseline, Week 4, 8, 12 ,16, 20 and 24
Title
Percentage of Participants Who Achieved ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16 and 20
Description
ASDAS includes CRP mg/L; four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included are total back pain (TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment (PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121*total back pain) + (0.110*participant global) + (0.073*peripheral pain/swelling) + (0.058* duration of morning stiffness) + (0.579*Ln(CRP+1)). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =>2 hours). Inactive disease is defined as an ASDAS score <1.3. ASDAS (CRP) Inactive Disease is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non- responders).
Time Frame
Week 4, 8, 12, 16, and 20
Title
Percentage of Participants With ASDAS (CRP) Major Improvement (Decrease >=2.0) Through Week 24
Description
ASDAS includes CRP mg/L; four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included are total back pain (TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment (PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121*TBP) + (0.110*participant global) + (0.073*peripheral pain/swelling) + (0.058* DMS) + (0.579*Ln(CRP+1)). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =>2 hours). Major improvement in ASDAS is defined as a decrease from baseline >=2.0. ASDAS (CRP) major improvement (decrease >=2.0) is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non- responders).
Time Frame
Baseline, Week 4, 8, 12, 16, 20 and 24
Title
Percentage of Participants Who Achieved ASDAS (CRP) Clinically Important Improvement (Decrease >=1.1) Through Week 24
Description
ASDAS includes CRP mg/L; four additional self-reported items (rated on 0-10cm VAS or 0-10 NRS) included are TBP, duration of DMS, peripheral pain/swelling and patient global assessment (PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121*TBP) + (0.110*participant global) + (0.073*peripheral pain/swelling) + (0.058*DMS) + (0.579*Ln(CRP+1)). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =>2 hours). Clinically important improvement in ASDAS is defined as a decrease from baseline >=1.1. ASDAS (CRP) clinical important improvement (decrease >=1.1) is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non- responders).
Time Frame
Baseline, Week 4, 8, 12, 16, 20 and 24
Title
Change From Baseline in BASFI at Week 4, 8, 12, 16 and 20
Description
The BASFI is composed with 10 questions (each question is answered with a visual analogue scale 0-10 cm) to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities of AS participants. Each question is a 10cm VAS with a value between 0 (easy) and 10 (impossible). The final BASFI score is the mean of the 10 scores. The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10. Higher BASFI score indicates more severe functional limitations of the participant due to AS. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).
Time Frame
Baseline, Week 4, 8, 12, 16 and 20
Title
Change From Baseline in Chest Expansion at Week 16 and 24
Description
Chest expansion is the difference, in centimeter (cm), between the circumference of the chest in maximal inspiration and maximal expiration. It is measured at the level of the fourth intercostal space in males, and just below the breasts in females. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).
Time Frame
Baseline, Week 16 and 24
Title
Change From Baseline in Total Back Pain (TBP) and Night Back Pain (NBP) Through Week 24
Description
The total back pain and nighttime back pain was measured on a VAS (0 to 10 cm; 0 = no pain, 10 = most severe pain). Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).
Time Frame
Baseline, Week 4, 8, 12, 16, 20 and 24
Title
Change From Baseline in Patients Global Assessment of Disease Activity Through Week 24
Description
Participants assessed their disease activity using a 10 cm visual analog scale, with responses ranging from 0 (very well) to 10 (very poor). Early escape rule was applied (The measurement value at Week 20 and Week 24 was set as missing).
Time Frame
Baseline, Week 4, 8, 12, 16, 20 and 24
Title
Change From Baseline in European Quality of Life 5 Dimension (EQ-5D) Visual Analog Scale (VAS) Score at Week 16 and 24
Description
The EQ-5D questionnaire is a brief, generic health-related quality of life assessment (HRQOL) that can also be used to incorporate participant preferences into health economic evaluations. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).
Time Frame
Baseline, Week 16 and 24
Title
Change From Baseline in EQ-5D Index Score at Week 16 and 24
Description
The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing death. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).
Time Frame
Baseline, Week 16 and 24
Title
Change From Baseline in Berlin Magnetic Resonance Imaging (MRI) Spine Score at Week 24
Description
The study used MRI with fat-saturating techniques such as short tau inversion recovery (STIR) to look for the presence of bone marrow edema. The Berlin modification of Ankylosing Spondylitis spine MRI score for activity (ASspiMRI-a) scoring technique assesses inflammation in each of the 23 disc vertebral units (DVU), capturing edema and erosion. Scores for each DVU range from 0-3 (0=normal; 1=minor bone marrow edema [less than or equal to 25% of DVU; 3=severe bone marrow edema (more that 50% of DVU)]. The composite score ranges from 0 to 69, with higher scores indicating more severe inflammation.
Time Frame
Baseline and Week 24
Title
Change From Baseline in Percent Work Time Missed Due to AS (Assessed by Work Productivity and Activity Impairment Questionnaire - Specific Health Problem [WPAI-SHP]) Through Week 24
Description
The WPAI-SHP is a 6-item questionnaire used to assess the degree to which a specified health problem (here "AS") affected work attendance, work productivity and productivity in non-work regular activities. Patients are asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity. change from baseline in percent work time missed due to AS for each study arm are reported.
Time Frame
Baseline, Week 16 and 24
Title
Change From Baseline in Percent Impairment While Working Due to AS (Assessed by WPAI-SHP) Through Week 24
Description
WPAI-SHP is 6-item questionnaire used to assess the degree to which a specified health problem ("AS") affected work attendance, work productivity and productivity in non-work regular activities. Patients are asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity. change from baseline in percent impairment while working due to AS for each study arm are reported.
Time Frame
Baseline, Week 16 and 24
Title
Change From Baseline in Percent Overall Work Impairment Due to AS (Assessed by WPAI-SHP) Through Week 24
Description
WPAI-SHP is 6-item questionnaire used to assess the degree to which a specified health problem (AS) affected work attendance, work productivity and productivity in non-work regular activities. Patients are asked to consider the past 7 days prior to each questionnaire day. Questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity. change from baseline in percent overall work impairment due to AS for each study arm are reported.
Time Frame
Baseline, Week 16 and 24
Title
Change From Baseline in Percent Non-work Activity Impairment Due to AS (Assessed by WPAI-SHP) Through Week 24
Description
WPAI-SHP is6-item questionnaire used to assess the degree to which a specified health problem (AS) affected work attendance, work productivity and productivity in non-work regular activities. Patients are asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity. change from baseline in percent non-work activity impairment due to AS for each study arm are reported.
Time Frame
Baseline, Week 16 and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must have a diagnosis of definite ankylosing spondylitis (AS), as defined by the modified 1984 New York criteria. The radiographic criterion must be confirmed by a central xray reader and at least 1 clinical criterion must be met Participants must have symptoms of active disease at screening and at baseline, as evidenced by both a BASDAI score of greater than or equal to (>=4) and a visual analog scale (VAS) score for total back pain of >=4, each on a scale of 0 to 10 Participants with elevated high sensitivity C-reactive protein (hsCRP) level of >=0.300 milligram per deciliter (mg/dL) at Screening If using nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesics for AS, must be on a stable dose for at least 2 weeks prior to the first administration of study agent. If currently not using NSAIDs or other analgesics for AS, must not have received NSAIDs or other analgesics for AS for at least 2 weeks prior to the first administration of the study agent A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test at Week 0 before randomization Exclusion Criteria: Participants who have other inflammatory diseases that might confound the evaluations of benefit from the ustekinumab therapy, including but not limited to, rheumatoid arthritis, systemic lupus erythematosus, or Lyme disease Participants who are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in the study or within 5 months after receiving the last administration of study agent Participants who have received any prior biologic therapy, including but not limited to anti-TNF alpha agents, tocilizumab, alefacept, efalizumab, natalizumab, abatacept, anakinra, ustekinumab, tidrakizumab or other anti-interleukin (IL) 23 biologics, brodalumab, secukinumab, ixekizumab, and B-cell depleting therapies Participants who have received any systemic immunosuppressives or disease-modifying antirheumatic drugs (DMARDs) other than methotrexate (MTX), sulfasalazine (SSZ), or hydroxychloroquine (HCQ) within 4 weeks prior to first administration of study agent. Medications in these categories include, but are not limited to chloroquine, azathioprine, cyclosporine, mycophenolate mofetil, gold, and penicillamine Participant who have received leflunomide within 3 months prior to the first administration of study agent (irrespective of undergoing a drug elimination procedure), or have received leflunomide within 12 months prior to the first administration of study agent and have not undergone a drug elimination procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
City
Peoria
State/Province
Arizona
Country
United States
City
Saint Petersburg
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Eagan
State/Province
Minnesota
Country
United States
City
Duncansville
State/Province
Pennsylvania
Country
United States
City
Wyomissing
State/Province
Pennsylvania
Country
United States
City
Jackson
State/Province
Tennessee
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Mesquite
State/Province
Texas
Country
United States
City
Seattle
State/Province
Washington
Country
United States
City
Brno
Country
Czechia
City
Bruntal
Country
Czechia
City
Kladno
Country
Czechia
City
Ostrava
Country
Czechia
City
Pardubice
Country
Czechia
City
Prague 5
Country
Czechia
City
Praha 2
Country
Czechia
City
Praha 4
Country
Czechia
City
Uherske Hradiste
Country
Czechia
City
Zlin
Country
Czechia
City
Daegu
Country
Korea, Republic of
City
Daejeon
Country
Korea, Republic of
City
Gwangju
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
City
Suwon
Country
Korea, Republic of
City
Bydgoszcz
Country
Poland
City
Szczecin
Country
Poland
City
Torun
Country
Poland
City
Warszawa
Country
Poland
City
Wrocław
Country
Poland
City
Chelyabinsk
Country
Russian Federation
City
Chita
Country
Russian Federation
City
Ivanovo
Country
Russian Federation
City
Kemerovo
Country
Russian Federation
City
Kirov
Country
Russian Federation
City
Kursk
Country
Russian Federation
City
Moscow
Country
Russian Federation
City
Novosibirsk
Country
Russian Federation
City
Orenburg
Country
Russian Federation
City
Petrozavodsk
Country
Russian Federation
City
Pyatigorsk
Country
Russian Federation
City
Sankt-Petersburg.
Country
Russian Federation
City
Saratov
Country
Russian Federation
City
St.Petersburg
Country
Russian Federation
City
Stavropol
Country
Russian Federation
City
Ufa
Country
Russian Federation
City
Ulyanovsk
Country
Russian Federation
City
Kaohsiung
Country
Taiwan
City
Taichung
Country
Taiwan
City
Tainan
Country
Taiwan
City
Taipei
Country
Taiwan
City
Taoyuan
Country
Taiwan
City
Ivano-Frankivsk
Country
Ukraine
City
Kharkiv
Country
Ukraine
City
Lviv
Country
Ukraine
City
Odessa
Country
Ukraine
City
Ternopil
Country
Ukraine
City
Vinnytsya
Country
Ukraine
City
Zaporizhzhya
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
30225992
Citation
Deodhar A, Gensler LS, Sieper J, Clark M, Calderon C, Wang Y, Zhou Y, Leu JH, Campbell K, Sweet K, Harrison DD, Hsia EC, van der Heijde D. Three Multicenter, Randomized, Double-Blind, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Ustekinumab in Axial Spondyloarthritis. Arthritis Rheumatol. 2019 Feb;71(2):258-270. doi: 10.1002/art.40728. Epub 2018 Dec 29.
Results Reference
derived

Learn more about this trial

A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNFα Naive Participants With Active Radiographic Axial Spondyloarthritis

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