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Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)

Primary Purpose

Ankylosing Spondylitis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Tofacitinib

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis

Eligibility Criteria

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

Inclusion Criteria:

Has a diagnosis of Ankylosing Spondylitis (AS) based on the Modified New York Criteria for AS (1984).
Must have a radiograph of SI joints (AP Pelvis) documenting diagnosis of AS.
Has active disease despite nonsteroidal anti-inflammatory drug (NSAID) therapy or intolerant to NSAIDs.

Exclusion Criteria:

History of known or suspected complete ankylosis of the spine.
History of allergies, intolerance or hypersensitivity to lactose or tofacitinib.
History of any other rheumatic disease.
Any subject with condition affecting oral drug absorption.

Sites / Locations

Rheumatology Associates of North Alabama, PC
Arizona Arthritis & Rheumatology Associates, P.C.
Medvin Clinical Research
Rheumatology Center of San Diego PC
University of California, San Francisco Medical Center
Robin K. Dore, MD, Inc.
New England Research Associates, LLC
Advanced Radiology
Stamford Therapeutics Consortium
Southcoast Research Center, Inc.
Millennium Research
Bluegrass Community Research, Inc
Center for Rheumatology and Bone Research
M3-Emerging Medical Research, LLC
Paramount Medical Research and Consulting, LLC
Oregon Health & Science University
Altoona Center For Clinical Research
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology
Precision Comprehensive Clinical Research Solutions
Adriana Pop-Moody MD - Clinic PA
Metroplex Clinical Research Center
Clinical Research Unit
Investigational Drug Services
Memorial Hermann Hospital Imaging
Southwest Rheumatology Research LLC
Trinity Universal Research Associates, Inc.
Advanced Rheumatology of Houston
Arthritis Northwest, PLLC
Pacific Radiology,
Rheumatology Research Unit Sunshine Coast
Emeritus Research Pty. Ltd.
Melbourne Radiology Clinic
SKG Radiology
Western Cardiology
RK Will Pty Ltd
Multiprofile Hospital for active treatment "Kaspela" EOOD
Diagnostic-Consulting Center XVII - Sofia
Medical Centre Synexus Sofia EOOD
Centre de Recherche Musculo-Squelettique
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
Guangdong Provincial People's Hospital
The Third Affiliated Hospital, Sun Yat-Sen University
The Second Affiliated Hospital of Zhejiang University School of Medicine
The First Affiliated Hosptial of Wenzhou Medical University
Rheumatology and Immunology Department, Shanghai Changzheng Hospital
Lekarna Rezidence Nova Karolina
CCBR Ostrava s.r.o.
BENU Lekarna
CCR, Czech a.s.
Lekarna Hradebni, s.r.o.
Uherskohradistska nemocnice, a.s.
Medical Plus s.r.o.
CHRU de Tours, Hopital Trousseau
Qualiclinic K ft
Pest megyei Flór Ferenc Kórház, Reumatológia-és Fizioterápiás Osztály
VITAL MEDICAL CENTER (VITÁL-MEDICINA Kft.)
Barzilai Medical Center
Chonnam National University Hospital
Inha University Hospital
Hanyang University Seoul Hospital
Geo Medical Sp. z.o.o Szpital Geo Medical
Moja Przychodnia
C.M. Silmedic Sp. z o.o.
Malopolskie Badania Kliniczne Sp. z o.o. s.k.
Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA
Centrum Medyczne Plejady
Centrum Medyczne LUX MED
Malopolskie Centrum Medyczne S.C.
Szpital Uniwersytecki w Krakowie, Zaklad Radiologii
Top Medical
Zespol Poradni Specjalistycznych REUMED, Wallenroda Filia nr 1
NZOZ JAMED Pracownia Rentgenowska Jerema Antoszewski
Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj
Klinika Alfa
RCMed Oddzial Sochaczew
Szpital Powiatowy w Sochaczewie
Szpital Sw. Elzbiety, Mokotowskie Centrum Medyczne, Zaklad Diagnostyki
"Reumatika - Centrum Reumatologii" NZOZ
Centrum Medyczne Oporow
Centrum Medyczne Medix
Limited Liability Company Medical Center "Rheuma-Med"
State Budgetary Healthcare Institution "Orenburg Regional Clinical Hospital"
Limited Liability Company "Sanavita"
State Healthcare Institution "Regional Clinical Hospital"
RSBHI "Smolensk Regional Clinical Hospital"
Limited Liability Company "BioMed"
Ankara Universitesi Tip Fakultesi Ibn-i Sina Hastanesi
Ankara Universitesi Tip Fakultesi, Ibn-i Sina Hastanesi
Hacettepe Universitesi Tip Fakultesi, Ic Hastaliklari Anabilim
Istanbul Universitesi Istanbul Tip Fakultesi, Ic Hastaliklari
Istanbul Universitesi Istanbul Tip Fakultesi
Marmara Univ. Istanbul Pendik Egitim ve Arastirma Hastanesi
Izmir Katip Celebi Univ Ataturk Egitim ve Arastirma Hastanesi
Izmir Katip Celebi Univ. Ataturk Egitim ve Arastirma Hastanesi
Kyiv City Clinical Hospital # 3, Rheumatology Department
Lviv Communal Clinical Hospital #4, Rheumatology department
Military-Medical Clinical Center (Clinical Hospital with 200 beds) of State Border Guard Service of
Ternopil University Hospital, Department of Rheumatology,
Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrohov, rheumatology department,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tofacitinib

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS)20 Response at Week 16

ASAS20 assess 4 domains: Patient Global Assessment of Disease (PGA) (assess disease activity on a scale of 0 [not active] to 10 [very active], high score=more disease activity), total back pain (scale of 0 [no pain] to 10 [most severe pain], high score=more severity), Function (Bath Ankylosing Spondylitis Functional Index [BASFI]; participant's level of ability on scale of 0 [easy] to 10 [impossible], low score= better functional health) and Inflammation (morning stiffness, Mean of Question [Q]5 and Q6 of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] defined as 6-item questionnaire measure disease activity on a scale of 0 [none] to 10 [severe], high score=more disease activity). ASAS20 response: greater than or equal to (>=) 20 percent (%) improvement from baseline in disease activity and absolute change of >=1 unit in >=3 domains and no worsening of >=20% and an absolute change of >=1 unit in remaining domain.

Secondary Outcome Measures

Percentage of Participants Achieving Ankylosing Spondylitis (ASAS)40 Response at Week 16

ASAS40 assessed 4 domains: the "PGA" (assess disease activity on a scale of 0 [not active] to 10 [very active], higher score=more disease activity), total back pain (on a scale of 0 [no pain] to 10 [most severe pain], higher score=more severity), Function (from BASFI: assess participant's level of ability on a scale of 0 [easy] to 10 [impossible], lower scores= better functional health) and Inflammation (morning stiffness, Mean of Q5 and Q6 of BASDAI defined as 6 item questionnaire: measures disease activity on a scale of 0 [none] to 10 [severe], higher score=more disease activity). ASAS40 response: >=40% and >=2 units improvement in >=3 domains and no worsening at all in the remaining domain.

Number of Participants With Treatment Emergent Adverse Events (AEs)

An AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03, severity was graded as Grade 1: asymptomatic/mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily living (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Treatment-emergent were events between first dose of study drug and up to 48 weeks that were absent before treatment or that worsened relative to pretreatment state.

Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity

AE: any untoward medical occurrence in subject who receive study drug without regard to possibility of causal relationship. Treatment-emergent AEs were events that occurred between first dose of study drug and up to 48 weeks that were absent before treatment or that worsened relative to pretreatment state. The severity grades (mild, moderate and severe) were defined as - mild: did not interfere with participant's usual function, moderate: Interfered to some extent with participant's usual function and severe: Interfered significantly with participant's usual function.

Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)

Hematology (Hemoglobin, Hematocrit, Erythrocyte, Lymphocyte/Leukocyte, Neutrophil/Leukocyte <0.8*Lower limit of normal (LLN), Reticulocyte >1.5*Upper limit of normal (ULN), Erythrocyte Mean Corpuscular Volume, Erythrocyte Mean Corpuscular Hemoglobin, Erythrocyte Mean Corpuscular HGB Concentration <0.9*LLN, >1.1*ULN, Reticulocyte/Erythrocyte, Leukocyte >1.5*ULN, Lymphocyte, Neutrophil <0.8*LLN and >1.2*ULN, Basophil, Basophil/Leukocyte, Eosinophil, Eosinophil/Leukocyte, Monocyte, Monocyte/Leukocyte >1.2*ULN); Clinical Chemistry (Bilirubin, Glucose >1.5*ULN, AST, ALT, Gamma Glutamyl Transferase >3.0*ULN, Urea, Creatinine, Triglyceride, Cholesterol >1.3*ULN, LDL Cholesterol>1.2*ULN, Potassium, C Reactive Protein >1.1*ULN, Bicarbonate <0.9*LLN, Creatine Kinase >2.0*ULN, HDL Cholesterol <0.8*LLN), Urinalysis (Specific Gravity >1.035, pH >8, Glucose, Ketones, Protein, Hemoglobin >=1, Erythrocyte, Leukocyte >=20, Granular Cast, Hyaline Cast>1.

Number of Participants With Vital Signs Abnormalities

Criteria for abnormalities in vital signs: Pulse rate <40 beats per minute (bpm) to >120 bpm, Sitting Diastolic blood pressure < 50 millimeter of mercury (mmHg), increase and decrease in change from baseline of >= 20mmHg, sitting systolic blood pressure < 90 mmHg, increase and decrease in change from baseline of >= 30mmHg.

Number of Participants With Abnormalities in Physical Examination

Complete physical examination: included general appearance, skin (presence of rash), heent (head, eyes, ears, nose and throat), lungs (auscultation), heart (auscultation for presence of murmurs, gallops, rubs), lower extremities (presence of peripheral edema), abdominal (palpation and auscultation), neurologic (mental status, station, gait, reflexes, motor and sensory function, coordination) and lymph nodes. Abnormalities in physical examination was based on investigator's discretion/clinical judgement.

Number of Participants With Electrocardiogram (ECG) Abnormalities

Twelve-lead electrocardiograms (ECGs) were obtained for all participants. Criteria for ECG abnormality: PR interval >=300 and a percent change from baseline of >=25 or 50%; QRS duration >=140 and a percent change from baseline of >=50%; QT interval >=500; QTCB, QTCF interval <480 or >=450, <500 or >=480, >=500, change from baseline of <60 and >=30, and change from baseline of >=60.

Percentage of Participants Achieving ASAS20 Response at Weeks 2, 4, 8, 12, 24, 32, 40 and 48

ASAS20 assess 4 domains: PGA of Disease (assess disease activity on a scale of 0 [not active] to 10 [very active], high score=more disease activity), total back pain (scale of 0 [no pain] to 10 [most severe pain], high score=more severity), Function (BASFI; participant's level of ability on scale of 0 [easy] to 10 [impossible], low score= better functional health) and Inflammation (morning stiffness, Mean of Q5 and Q6 of BASDAI defined as 6-item questionnaire measure disease activity on a scale of 0 [none] to 10 [severe], high score=more disease activity). ASAS20 response: >= 20% improvement from baseline in disease activity and absolute change of >=1 unit in >=3 domains and no worsening of >=20% and an absolute change of >=1 unit in remaining domain.

Percentage of Participants Achieving ASAS40 Response at Weeks 2, 4, 8, 12, 24, 32, 40 and 48

Change From Baseline in Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

ASDAS(CRP) was derived using BASDAI (6-item questionnaire measures disease activity on a scale of 0 [none] to 10 [severe], higher score=more disease activity) and PGA (measure disease activity on a scale of 0 [not active] to 10 [very active], high score=more disease activity) and calculated by using the following formula, 0.121 x Back Pain (Q2 of BASDAI) + 0.058 x Duration of Morning Stiffness (Q6 of BASDAI) + 0.110 x PGA + 0.073 x Peripheral Pain/Swelling (Q3 of BASDAI) + 0.579 x Ln(high sensitivity [hs] CRP mg/Liter [L] + 1). If hsCRP values were smaller than 2 mg/L, they were set to 2 mg/L in the formula. The range of score was >= 0.636 to no defined upper limit. A negative change from baseline value indicates decrease in disease activity; a positive change from baseline value indicates increase in disease activity.

Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Blood samples were collected for analysis of hsCRP using an assay analyzed by central laboratory. hsCRP is an acute phase reactant, which was indicative of inflammation and of its severity.

Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score at Weeks 16 and 48

The ASQoL was an 18-item questionnaire assessed the amount of restriction participant experienced in daily activities, level of pain and fatigue, and the impact on the participant's emotional state. Each item was scored as 0 (no impact) or 1 (yes - impact). A total score was calculated by summing the items. The total score ranged from 0 (no impact) to 18 (yes-impact), with higher values indicated more impaired health-related quality of life.

Change From Baseline in Short-Form-36 Health Survey-Version 2 Acute (SF-36v2) Score at Weeks 16 and 48

SF-36 v.2 (Acute): 36-item generic health status measure. It measured 8 general health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, mental health. These domains were aggregated into 2 summary scores - physical component summary (PCS), mental component summary (MCS). Four domains comprised PCS score (physical functioning, role-physical, bodily pain, general health) and remaining 4 domains comprised MCS score (vitality, social functioning, role-emotional, mental health). Normalized domain scores, PCS, MCS scores are used in analyses. Component and domain scores were scored by using United States 1998 general population norm. Resulting norm-based T-scores for both the SF36 version 2 and SF36 health domain scale and component summary measures had means of 50 and standard deviations of 10. Higher PCS/MCS/domain score represent better health status.

Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Cervical Rotation Angle at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

BASMI assess axial status and spinal mobility. It composed of 5 clinical measures: lateral spinal flexion, tragus-to-wall distance, lumbar flexion (modified Schober), maximal intermalleolar distance, cervical rotation. BASMI - Linear Method score was average of 5 individual component score mapped between 0 and 10, high score=more impairment of axial status, spinal mobility. For cervical rotation angle, participant sit straight on chair with chin level and hands on knees. Blinded assessor place goniometer at top of head in line with nose and ask participant to rotate neck maximally to left, follows with goniometer and record angle between sagittal plane and new plane after rotation. A second reading obtained and both readings recorded. Procedure repeated for right side. Better of two for each side was selected for scoring. Scoring done by calculating mean of left and right measurement and recorded in degrees (range: 0 to 90), higher cervical rotation value=better health status.

Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Intermalleolar Distance at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

BASMI assessed axial status and spinal mobility, using linear function. It composed of 5 clinical measures: lateral spinal flexion, tragus-to-wall distance, lumbar flexion (modified Schober), maximal intermalleolar distance, cervical rotation. BASMI - Linear Method score was average of 5 individual component scores mapped between 0 and 10, with higher scores indicating more impairment of axial status and spinal mobility. For the assessment of intermalleolar distances, participant should lie supine with the knees straight and feet/toes pointing straight up and asked to separate the legs as far as possible and the distance between the medial malleoli was measured (in Centimeters [cm] to the nearest 0.1 cm). Distance (in cm) was greater than or equal to 0, with no maximum defined range: higher intermalleolar distance value indicates better health status.

Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Lateral Spinal Flexion at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

BASMI assess axial status, spinal mobility, using linear function. It composed of 5 clinical measures. BASMI - Linear Method score-average of 5 component scores mapped between 0 and 10, with high scores =more impairment of axial status, spinal mobility. For assessment of lateral spinal flexion: participant stand upright with head and back rest against wall as close as possible with shoulders level and feet 30 cm apart and feet parallel. At tip of middle finger, place a mark on thigh. This neutral position recorded. Participant bend sideways without bending knees or lifting heels while attempting to keep shoulders in same position (flexion position). Second mark placed, lateral flexion recorded (left or right as appropriate) using cm tape measure. Two tries for left, two tries for right measured. Result of two tries recorded for left and right separately in cm to nearest 0.1 cm. Distance (in cm) should be >=0, with no maximum defined range: high value indicates better health status.

Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Lumbar Flexion (Modified Schober) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

BASMI assessed axial status and spinal mobility. BASMI - Linear Method score was average of 5 individual component scores mapped between 0 and 10, with higher scores indicating more impairment of axial status and spinal mobility. For the assessment of lumbar flexion, With the participant standing erect and outer edges of feet 30 cm apart, a mark was placed in the midpoint of a line that joins the posterior superior iliac spines (baseline mark). A second mark (A) was placed 10 cm above the baseline mark and a third mark (B) 5 cm below the baseline mark. Then have the participant maximally bend forward, keeping the knees fully extended. With the participant's spine in full flexion, the distance between marks A and B (in cm to the nearest 0.1 cm) was re-measured. Distance (in cm) was greater than or equal to 0, with no maximum defined range. Higher value indicates better health status.

Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Tragus-to-wall Distance at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

BASMI assessed axial status and spinal mobility, using linear function. It composed of 5 clinical measures: lateral spinal flexion, tragus-to-wall distance, lumbar flexion (modified Schober), maximal intermalleolar distance, cervical rotation. BASMI - Linear Method score was average of 5 individual component scores mapped between 0 and 10, with higher scores indicating more impairment of axial status and spinal mobility. For the assessment of tragus-to-wall distance, participant was placed standing with his/her back against the wall; knees straight; scapulae, buttocks, and heels against wall; and head in as neutral position as possible. The distance between the tragus and wall in cm was measured (to the nearest 0.1 cm) from both the right side and left side at the maximum effort to touch the head against the wall. Distance should be greater than or equal to 0 cm with no defined maximum value, lower tragus-to-wall value indicates better health status.

Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Linear Method Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

The BASMI was used to assess the axial status and spinal mobility (cervical, dorsal and lumbar spine, hips and pelvic soft tissue) and was analyzed using the linear function method. BASMI score composed of five clinical measures: lateral spinal flexion, tragus-to-wall distance, lumbar flexion (modified Schober), maximal intermalleolar distance, and cervical rotation. BASMI - Linear Method score was the average of 5 individual component scores mapped between 0 and 10 and thus the BASMI - Linear Method total score ranged from 0 (very good) to 10 (very poor), wherein higher scores indicated more impairment of axial status and spinal mobility; lower scores indicated better health status.

Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

FACIT-F is a 13-item questionnaire (felt fatigued, felt weak all over, felt listless ["washed out"],felt tired, had energy, had trouble starting things as tired, had trouble finishing things as tired, was able to do usual activities, needed to sleep during day, too tired to eat, needed help doing my usual activities, frustrated by being too tired to do things wanted to do, had to limit my social activity because tired), with each item scored on a 5-point scale ranging from 0 (not at all) to 4 (very much). Three type of scores were derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score was calculated by summing the 13 items (range 0 [not at all] to 52 [very much]); higher scores represent less fatigue status. In this outcome measure, change from baseline in FACIT-F total score was reported.

Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

FACIT-F is a 13-item (felt fatigued, felt weak all over, felt listless ["washed out"],felt tired, had energy, had trouble starting things as tired, had trouble finishing things as tired, was able to do usual activities, needed to sleep during day, too tired to eat, needed help doing my usual activities, frustrated by being too tired to do things wanted to do, had to limit my social activity because tired) questionnaire, with each item scored on a 5-point scale ranging from 0 (not at all) to 4 (very much). FACIT-F experience domain score was calculated by summing 5 items: I feel fatigued, I feel weak all over, I feel listless ("washed out"), I feel tired, and I have energy. FACIT-F total experience domain score ranged from 0 (not at all) to 20 (very much), with higher scores represented better (less) fatigue impact on daily functioning. In this outcome measure, change from baseline in FACIT-F experience domain score was reported.

Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

FACIT-F is a 13-item (felt fatigued, felt weak all over, felt listless ["washed out"],felt tired, had energy, had trouble starting things as tired, had trouble finishing things as tired, was able to do usual activities, needed to sleep during day, too tired to eat, needed help doing my usual activities, frustrated by being too tired to do things wanted to do, had to limit my social activity because tired) questionnaire, with each item scored on a 5-point scale ranging from 0 (not at all) to 4 (very much). FACIT-F experience domain score calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless, I feel tired, and I have energy, while FACIT-F impact domain score was calculated by summing the remaining 8 items. FACIT-F impact domain score ranged from 0 (not at all) to 32 (very much), with higher scores represented better (less) fatigue impact on daily functioning. In this outcome measure, change from baseline in FACIT-F impact domain score was reported.

Change From Baseline in Patient's Global Assessment of Disease (PGA) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Participants answered the question, "How active was your spondylitis on average during the last week?. Participant's response was recorded using a numerical rating scale ranged from 0 (Not Active) to 10 (Very Active), with higher scores indicated more severe disease.

Change From Baseline in Patient's Assessment of Spinal Pain: Total Back Pain at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Participants marked their level of total back pain on a numerical rating scale (NRS) ranged from 0 (no pain) to 10 (most severe pain), with higher scores indicated more severe pain.

Change From Baseline in Patient's Assessment of Spinal Pain: Nocturnal Spinal Pain at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Participants marked their level of nocturnal spinal pain on a NRS ranged from 0 (no pain) to 10 (most severe pain), with higher scores indicated more severe pain.

Change From Baseline in in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

BASFI was a functional index which included 10 items assessing ability of participants to perform normal daily activities. The first 8 questions/items consider activities related to functional anatomy. The final 2 questions/items assess the participants' ability to cope with everyday life. Each item was scored on a scale of 0=easy to 10=impossible. The BASFI total score was calculated as the average score of these 10 individual items. BASFI total score ranged from 0 (easy) to 10 (impossible), where higher scores indicated more severe disease activity.

Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Inflammation (Morning Stiffness) Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

The BASDAI was a validated questionnaire that consisted of 6 questions pertaining to the 5 major symptoms of AS: fatigue; spinal pain; peripheral arthritis; enthesitis, intensity of morning stiffness and duration of morning stiffness. Each question was rated using a numerical rating scale from 0 (none) to 10 (very severe), higher score=high disease activity. The BASDAI score was calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions 1 to 4. This score was then divided by 5. The total BASDAI score was ranged from 0= none to 10= very severe, where higher score indicated high disease activity. BASDAI inflammation score was derived by taking mean of the responses of question 5 and 6 and ranged from 0 (none) to 10 (very severe), where higher score indicated more inflammation (morning stiffness).

Percentage of Participants Achieving ASAS 5/6 Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

ASAS 5/6 consists of 6 domains: 4 used in ASAS20 - PGA (assess disease activity on a scale of 0 [not active] to 10 [very active], higher score=more disease activity), Spinal Pain (total back pain) (on a scale of 0 [no pain] to 10 [most severe pain], higher score=more severity), Function (using BASFI which assess participant's level of ability on a scale of 0 [easy] to 10 [impossible], lower scores= better functional health) and Inflammation (using BASDAI, mean of Q 5 and 6, which assess disease activity on a scale of 0 [none] to 10 [severe], higher score=more disease activity), CRP (was measured in mg per liter) and Spinal mobility was measured in centimeter and calculated as mean of right and left measurements of lateral spinal flexion from BASMI. ASAS 5/6: defined as >=20% improvement in at least 5 domains.

Percentage of Participants Achieving ASAS Partial Remission at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Partial remission was defined as a score of 2 or less (on a scale of 0-10, where 0=no disease activity and 10=high disease activity) in each of the 4 domains in ASAS. These 4 domains included: PGA (assess disease activity on a scale of 0 [not active] to 10 [very active], higher score=more disease activity), total back pain (on a scale of 0 [no pain] to 10 [most severe pain], higher score=more severity), Function (using BASFI which assess participant's level of ability on a scale of 0 [easy] to 10 [impossible], lower scores= better functional health) and Inflammation (using BASDAI, mean of Q 5 and 6, which assess disease activity on a scale of 0 [none] to 10 [severe], higher score=more disease activity).

Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

The BASDAI was a validated questionnaire that consisted of 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis: fatigue; spinal pain; peripheral arthritis; enthesitis, intensity of morning stiffness and duration of morning stiffness. Each question was rated using a numerical rating scale from 0 (none) to 10 (very severe), higher score=high disease activity. The BASDAI score was calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions 1 to 4. This score was then divided by 5. The total BASDAI score was ranged from 0= none to 10= very severe, where higher score indicated high disease activity.

Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

BASDAI was a validated questionnaire that consisted of 6 questions pertaining to the 5 major symptoms of AS: fatigue; spinal pain; peripheral arthritis; enthesitis, intensity of morning stiffness and duration of morning stiffness. Each question was rated using a numerical rating scale from 0 (none) to 10 (very severe), higher score=high disease activity. BASDAI score was calculated by computing mean of questions 5 and 6 and adding it to sum of questions 1 to 4. This score was then divided by 5. The total BASDAI score was ranged from 0= none to 10= very severe, where higher score indicated high disease activity. BASDAI50 response was defined as decrease of >=50% from Baseline in BASDAI score at specified time points. Percentage of participants with BASDAI 50 response at specified weeks are reported.

Percentage of Participants With Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Clinically Important Improvement Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

ASDAS(CRP) was derived using BASDAI (6-item questionnaire measures disease activity on a scale of 0 [none] to 10 [severe], higher score=more disease activity) and PGA (measure disease activity on a scale of 0 [not active] to 10 [very active], high score=more disease activity) and by using the following formula, 0.121 x Back Pain (Q2 of BASDAI) + 0.058 x Duration of Morning Stiffness (Q6 of BASDAI) + 0.110 x PGA + 0.073 x Peripheral Pain/Swelling (Q3 of BASDAI) + 0.579 x Ln(hsCRP mg/L + 1). If hsCRP values were smaller than 2 mg/L, they were set to 2 mg/L in the formula. The range of score was >= 0.636 to no defined upper limit. A negative change from baseline value indicates decrease in disease activity; a positive change from baseline value indicates increase in disease activity. ASDAS(CRP) clinically important improvement was defined as decrease from Baseline of >=1.1 units in ASDAS(CRP) score.

Percentage of Participants Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Major Improvement Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

ASDAS(CRP) was derived using BASDAI (6-item questionnaire measures disease activity on a scale of 0 [none] to 10 [severe], higher score=more disease activity) and PGA (measure disease activity on a scale of 0 [not active] to 10 [very active], high score=more disease activity) and by using the following formula, 0.121 x Back Pain (Q2 of BASDAI) + 0.058 x Duration of Morning Stiffness (Q6 of BASDAI) + 0.110 x PGA + 0.073 x Peripheral Pain/Swelling (Q3 of BASDAI) + 0.579 x Ln(hsCRP mg/L + 1). If hsCRP values were smaller than 2 mg/L, they were set to 2 mg/L in the formula. The range of score was >= 0.636 to no defined upper limit. A negative change from baseline value indicates decrease in disease activity; a positive change from baseline value indicates increase in disease activity. ASDAS(CRP) major improvement was defined as a response if improvement (decrease) from Baseline in ASDAS(CRP) of >=2.0 units.

Percentage of Participants Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Inactive Disease Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

ASDAS(CRP) was derived using BASDAI (6-item questionnaire measures disease activity on a scale of 0 [none] to 10 [severe], higher score=more disease activity) and PGA (measure disease activity on a scale of 0 [not active] to 10 [very active], high score=more disease activity) and by using the following formula, 0.121 x Back Pain (Q2 of BASDAI) + 0.058 x Duration of Morning Stiffness (Q6 of BASDAI) + 0.110 x PGA + 0.073 x Peripheral Pain/Swelling (Q3 of BASDAI) + 0.579 x Ln(hsCRP mg/L + 1). If hsCRP values were smaller than 2 mg/L, they were set to 2 mg/L in the formula. The range of score was >= 0.636 to no defined upper limit. A negative change from baseline value indicates decrease in disease activity; a positive change from baseline value indicates increase in disease activity. ASDAS(CRP) inactive disease is defined as a response if actual ASDAS(CRP) was <1.3 units.

Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Weeks 4, 8, 12, 16, 24, 32, 40 and 48

The MASES is an index used to measure the severity of enthesitis. Enthesitis is the inflammation of enthuses (heels). The MASES assesses 13 sites for enthesitis. Sites assessed included 1st costochondral joint (left [l]/right [r]), 7th costochondral joint (l/r), posterior superior iliac spine (l/r), posterior anterior iliac spine (l/r), iliac crest (l/r), proximal insertion of Achilles tendon (l/r) and 5th lumbar spinous process. Each site was graded for the presence (1) and absence (0) of tenderness yielding total MASES score ranging from 0 (no tenderness) to 13 (worst possible score) with higher score indicated more severe tenderness.

Change From Baseline in Swollen Joint Count (SJC) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Swollen joint count was an assessment on 44 joints (sternoclaviculars, acromioclaviculars, shoulders, elbows, wrists, metacarpophalangeals, thumb interphalangeal, proximal interphalangeals, knees, ankles, and metatarsophalangeals). Each joint was assessed for swelling as: Present or Absent. Artificial joints were not assessed

Change From Baseline in Spinal Mobility (Chest Expansion ) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Chest expansion (measured in centimeters (cm), is defined as the difference in the thoracic circumference during full expiration versus full inspiration. This was measured at the 4th intercostal space. The difference between maximal inspiration and expiration of the two attempts was recorded. The better of the two attempts was used to calculate chest expansion which was defined to be greater than or equal to 0 cm with no defined maximum/upper limit. Greater chest circumference corresponds to higher score indicated more spinal mobility/better health status (measured as Chest Expansion in cm).

Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Score at Weeks 16 and 48

EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions. Participants rated 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The mean of the summed score ranged from 1 to 3 with "1" corresponding to no problems and "3" corresponding to severe problems in the 5 dimensions, where higher score indicates more severe problems.

Change From Baseline in EuroQol Visual Analogue Scale (EQ-VAS) Score (mm) at Weeks 16 and 48

EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions. Its second part included EQ-VAS. EQ-VAS recorded the participant's self-rated health on a VAS ranging from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state), with higher scores indicating better health state.

Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed Due to Health Problem at Weeks 16 and 48

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which Ankylosing Spondylitis affected work productivity and regular activities over the past 7 days. The questions are as follows: Q1 = currently employed; Q2 = hours missed due to health problems; Q3 = hours missed due to other reasons; Q4 = hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, with higher numbers indicating less productivity); Q6 = degree health affected regular activities (0-10 scale, with higher numbers indicating greater impairment of regular activities). Percent work time missed due to health problem was a subscale and calculated as: Q2/(Q2+Q4) for those who were currently employed. Subscale score was expressed as an impairment percentage (range: 0-100%) where higher numbers indicate greater impairment and less productivity.

Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working Due to Health Problem at Weeks 16 and 48

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which Ankylosing Spondylitis affected work productivity and regular activities over the past 7 days. The questions are as follows: Q1 = currently employed; Q2 = hours missed due to health problems; Q3 = hours missed due to other reasons; Q4 = hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, with higher numbers indicating less productivity); Q6 = degree health affected regular activities (0-10 scale, with higher numbers indicating greater impairment of regular activities). Percent Impairment while Working due to Health Problem was a subscale and calculated as: Q5/10 for those who were currently employed and actually worked in the past 7 days. Subscale score was expressed as an impairment percentage (range: 0-100%) where higher numbers indicate greater impairment and less productivity.

Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment Due to Health Problem at Weeks 16 and 48

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which Ankylosing Spondylitis affected work productivity and regular activities over the past 7 days. The questions are as follows: Q1 = currently employed; Q2 = hours missed due to health problems; Q3 = hours missed due to other reasons; Q4 = hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, with higher numbers indicating less productivity); Q6 = degree health affected regular activities (0-10 scale, with higher numbers indicating greater impairment of regular activities). Percent overall work impairment due to health problem was a subscale and calculated as: Q2/(Q2+Q4)+[(1- Q2/(Q2+Q4))×(Q5/10)] for those who were currently employed. Subscale score was expressed as an impairment percentage (range: 0-100%) where higher numbers indicate greater impairment.

Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment Due to Health Problem at Weeks 16 and 48

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which Ankylosing Spondylitis affected work productivity and regular activities over the past 7 days. The questions are as follows: Q1 = currently employed; Q2 = hours missed due to health problems; Q3 = hours missed due to other reasons; Q4 = hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, with higher numbers indicating less productivity); Q6 = degree health affected regular activities (0-10 scale, with higher numbers indicating greater impairment of regular activities). Percent activity impairment due to health problem was a subscale and calculated as: Q6/10 for all respondents. Subscale score was expressed as an impairment percentage (range: 0-100%) where higher numbers indicate greater impairment.

Full Information

NCT ID

NCT03502616

First Posted

April 11, 2018

Last Updated

August 19, 2021

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT03502616

Brief Title

Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)

Official Title

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

June 7, 2018 (Actual)

Primary Completion Date

December 19, 2019 (Actual)

Study Completion Date

August 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine if tofacitinib is safe and effective in subjects with active ankylosing spondylitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ankylosing Spondylitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

270 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tofacitinib

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Tofacitinib

Intervention Description

Oral administration twice per day

Primary Outcome Measure Information:

Title

Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS)20 Response at Week 16

Description

Time Frame

Week 16

Secondary Outcome Measure Information:

Title

Percentage of Participants Achieving Ankylosing Spondylitis (ASAS)40 Response at Week 16

Description

Time Frame

Week 16

Title

Number of Participants With Treatment Emergent Adverse Events (AEs)

Description

Time Frame

Baseline up to Week 16 and Baseline up to Week 48

Title

Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity

Description

Time Frame

Baseline up to Week 16 and Baseline up to Week 48

Title

Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)

Description

Time Frame

Baseline up to Week 16 and Baseline up to Week 48

Title

Number of Participants With Vital Signs Abnormalities

Description

Time Frame

Baseline up to Week 16 and Baseline up to Week 48

Title

Number of Participants With Abnormalities in Physical Examination

Description

Time Frame

Screening, Week 16, and Week 48

Title

Number of Participants With Electrocardiogram (ECG) Abnormalities

Description

Time Frame

Baseline up to Week 16, Baseline up to Week 48

Title

Percentage of Participants Achieving ASAS20 Response at Weeks 2, 4, 8, 12, 24, 32, 40 and 48

Description

Time Frame

Weeks 2, 4, 8, 12, 24, 32, 40 and 48

Title

Percentage of Participants Achieving ASAS40 Response at Weeks 2, 4, 8, 12, 24, 32, 40 and 48

Description

Time Frame

Weeks 2, 4, 8, 12, 24, 32, 40 and 48

Title

Change From Baseline in Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Title

Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Description

Blood samples were collected for analysis of hsCRP using an assay analyzed by central laboratory. hsCRP is an acute phase reactant, which was indicative of inflammation and of its severity.

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Title

Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score at Weeks 16 and 48

Description

Time Frame

Baseline, Weeks 16 and 48

Title

Change From Baseline in Short-Form-36 Health Survey-Version 2 Acute (SF-36v2) Score at Weeks 16 and 48

Description

Time Frame

Baseline, Weeks 16 and 48

Title

Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Cervical Rotation Angle at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Title

Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Intermalleolar Distance at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Title

Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Lateral Spinal Flexion at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Title

Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Lumbar Flexion (Modified Schober) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Title

Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Tragus-to-wall Distance at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Description

BASMI assessed axial status and spinal mobility, using linear function. It composed of 5 clinical measures: lateral spinal flexion, tragus-to-wall distance, lumbar flexion (modified Schober), maximal intermalleolar distance, cervical rotation. BASMI - Linear Method score was average of 5 individual component scores mapped between 0 and 10, with higher scores indicating more impairment of axial status and spinal mobility. For the assessment of tragus-to-wall distance, participant was placed standing with his/her back against the wall; knees straight; scapulae, buttocks, and heels against wall; and head in as neutral position as possible. The distance between the tragus and wall in cm was measured (to the nearest 0.1 cm) from both the right side and left side at the maximum effort to touch the head against the wall. Distance should be greater than or equal to 0 cm with no defined maximum value, lower tragus-to-wall value indicates better health status.

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Title

Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Linear Method Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Title

Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Title

Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Title

Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Description

FACIT-F is a 13-item (felt fatigued, felt weak all over, felt listless ["washed out"],felt tired, had energy, had trouble starting things as tired, had trouble finishing things as tired, was able to do usual activities, needed to sleep during day, too tired to eat, needed help doing my usual activities, frustrated by being too tired to do things wanted to do, had to limit my social activity because tired) questionnaire, with each item scored on a 5-point scale ranging from 0 (not at all) to 4 (very much). FACIT-F experience domain score calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless, I feel tired, and I have energy, while FACIT-F impact domain score was calculated by summing the remaining 8 items. FACIT-F impact domain score ranged from 0 (not at all) to 32 (very much), with higher scores represented better (less) fatigue impact on daily functioning. In this outcome measure, change from baseline in FACIT-F impact domain score was reported.

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Title

Change From Baseline in Patient's Global Assessment of Disease (PGA) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Title

Change From Baseline in Patient's Assessment of Spinal Pain: Total Back Pain at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Description

Participants marked their level of total back pain on a numerical rating scale (NRS) ranged from 0 (no pain) to 10 (most severe pain), with higher scores indicated more severe pain.

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Title

Change From Baseline in Patient's Assessment of Spinal Pain: Nocturnal Spinal Pain at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Description

Participants marked their level of nocturnal spinal pain on a NRS ranged from 0 (no pain) to 10 (most severe pain), with higher scores indicated more severe pain.

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Title

Change From Baseline in in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Title

Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Inflammation (Morning Stiffness) Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Title

Percentage of Participants Achieving ASAS 5/6 Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Description

Time Frame

Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Title

Percentage of Participants Achieving ASAS Partial Remission at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Description

Time Frame

Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Title

Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Title

Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Description

Time Frame

Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Title

Description

ASDAS(CRP) was derived using BASDAI (6-item questionnaire measures disease activity on a scale of 0 [none] to 10 [severe], higher score=more disease activity) and PGA (measure disease activity on a scale of 0 [not active] to 10 [very active], high score=more disease activity) and by using the following formula, 0.121 x Back Pain (Q2 of BASDAI) + 0.058 x Duration of Morning Stiffness (Q6 of BASDAI) + 0.110 x PGA + 0.073 x Peripheral Pain/Swelling (Q3 of BASDAI) + 0.579 x Ln(hsCRP mg/L + 1). If hsCRP values were smaller than 2 mg/L, they were set to 2 mg/L in the formula. The range of score was >= 0.636 to no defined upper limit. A negative change from baseline value indicates decrease in disease activity; a positive change from baseline value indicates increase in disease activity. ASDAS(CRP) clinically important improvement was defined as decrease from Baseline of >=1.1 units in ASDAS(CRP) score.

Time Frame

Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Title

Percentage of Participants Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Major Improvement Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Description

ASDAS(CRP) was derived using BASDAI (6-item questionnaire measures disease activity on a scale of 0 [none] to 10 [severe], higher score=more disease activity) and PGA (measure disease activity on a scale of 0 [not active] to 10 [very active], high score=more disease activity) and by using the following formula, 0.121 x Back Pain (Q2 of BASDAI) + 0.058 x Duration of Morning Stiffness (Q6 of BASDAI) + 0.110 x PGA + 0.073 x Peripheral Pain/Swelling (Q3 of BASDAI) + 0.579 x Ln(hsCRP mg/L + 1). If hsCRP values were smaller than 2 mg/L, they were set to 2 mg/L in the formula. The range of score was >= 0.636 to no defined upper limit. A negative change from baseline value indicates decrease in disease activity; a positive change from baseline value indicates increase in disease activity. ASDAS(CRP) major improvement was defined as a response if improvement (decrease) from Baseline in ASDAS(CRP) of >=2.0 units.

Time Frame

Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Title

Percentage of Participants Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Inactive Disease Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Description

ASDAS(CRP) was derived using BASDAI (6-item questionnaire measures disease activity on a scale of 0 [none] to 10 [severe], higher score=more disease activity) and PGA (measure disease activity on a scale of 0 [not active] to 10 [very active], high score=more disease activity) and by using the following formula, 0.121 x Back Pain (Q2 of BASDAI) + 0.058 x Duration of Morning Stiffness (Q6 of BASDAI) + 0.110 x PGA + 0.073 x Peripheral Pain/Swelling (Q3 of BASDAI) + 0.579 x Ln(hsCRP mg/L + 1). If hsCRP values were smaller than 2 mg/L, they were set to 2 mg/L in the formula. The range of score was >= 0.636 to no defined upper limit. A negative change from baseline value indicates decrease in disease activity; a positive change from baseline value indicates increase in disease activity. ASDAS(CRP) inactive disease is defined as a response if actual ASDAS(CRP) was <1.3 units.

Time Frame

Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Title

Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Weeks 4, 8, 12, 16, 24, 32, 40 and 48

Description

Time Frame

Baseline, Weeks 4, 8, 12, 16, 24, 32, 40 and 48

Title

Change From Baseline in Swollen Joint Count (SJC) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Title

Change From Baseline in Spinal Mobility (Chest Expansion ) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Title

Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Score at Weeks 16 and 48

Description

Time Frame

Baseline, Weeks 16 and 48

Title

Change From Baseline in EuroQol Visual Analogue Scale (EQ-VAS) Score (mm) at Weeks 16 and 48

Description

Time Frame

Baseline, Weeks 16 and 48

Title

Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed Due to Health Problem at Weeks 16 and 48

Description

Time Frame

Baseline, Weeks 16 and 48

Title

Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working Due to Health Problem at Weeks 16 and 48

Description

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which Ankylosing Spondylitis affected work productivity and regular activities over the past 7 days. The questions are as follows: Q1 = currently employed; Q2 = hours missed due to health problems; Q3 = hours missed due to other reasons; Q4 = hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, with higher numbers indicating less productivity); Q6 = degree health affected regular activities (0-10 scale, with higher numbers indicating greater impairment of regular activities). Percent Impairment while Working due to Health Problem was a subscale and calculated as: Q5/10 for those who were currently employed and actually worked in the past 7 days. Subscale score was expressed as an impairment percentage (range: 0-100%) where higher numbers indicate greater impairment and less productivity.

Time Frame

Baseline, Weeks 16 and 48

Title

Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment Due to Health Problem at Weeks 16 and 48

Description

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which Ankylosing Spondylitis affected work productivity and regular activities over the past 7 days. The questions are as follows: Q1 = currently employed; Q2 = hours missed due to health problems; Q3 = hours missed due to other reasons; Q4 = hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, with higher numbers indicating less productivity); Q6 = degree health affected regular activities (0-10 scale, with higher numbers indicating greater impairment of regular activities). Percent overall work impairment due to health problem was a subscale and calculated as: Q2/(Q2+Q4)+[(1- Q2/(Q2+Q4))×(Q5/10)] for those who were currently employed. Subscale score was expressed as an impairment percentage (range: 0-100%) where higher numbers indicate greater impairment.

Time Frame

Baseline, Weeks 16 and 48

Title

Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment Due to Health Problem at Weeks 16 and 48

Description

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which Ankylosing Spondylitis affected work productivity and regular activities over the past 7 days. The questions are as follows: Q1 = currently employed; Q2 = hours missed due to health problems; Q3 = hours missed due to other reasons; Q4 = hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, with higher numbers indicating less productivity); Q6 = degree health affected regular activities (0-10 scale, with higher numbers indicating greater impairment of regular activities). Percent activity impairment due to health problem was a subscale and calculated as: Q6/10 for all respondents. Subscale score was expressed as an impairment percentage (range: 0-100%) where higher numbers indicate greater impairment.

Time Frame

Baseline, Weeks 16 and 48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Has a diagnosis of Ankylosing Spondylitis (AS) based on the Modified New York Criteria for AS (1984). Must have a radiograph of SI joints (AP Pelvis) documenting diagnosis of AS. Has active disease despite nonsteroidal anti-inflammatory drug (NSAID) therapy or intolerant to NSAIDs. Exclusion Criteria: History of known or suspected complete ankylosis of the spine. History of allergies, intolerance or hypersensitivity to lactose or tofacitinib. History of any other rheumatic disease. Any subject with condition affecting oral drug absorption.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Rheumatology Associates of North Alabama, PC

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

Facility Name

Arizona Arthritis & Rheumatology Associates, P.C.

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85297

Country

United States

Facility Name

Medvin Clinical Research

City

Covina

State/Province

California

ZIP/Postal Code

91722

Country

United States

Facility Name

Rheumatology Center of San Diego PC

City

San Diego

State/Province

California

ZIP/Postal Code

92128

Country

United States

Facility Name

University of California, San Francisco Medical Center

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Facility Name

Robin K. Dore, MD, Inc.

City

Tustin

State/Province

California

ZIP/Postal Code

92780

Country

United States

Facility Name

New England Research Associates, LLC

City

Bridgeport

State/Province

Connecticut

ZIP/Postal Code

06606

Country

United States

Facility Name

Advanced Radiology

City

Stamford

State/Province

Connecticut

ZIP/Postal Code

06902

Country

United States

Facility Name

Stamford Therapeutics Consortium

City

Stamford

State/Province

Connecticut

ZIP/Postal Code

06905

Country

United States

Facility Name

Southcoast Research Center, Inc.

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Millennium Research

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

Country

United States

Facility Name

Bluegrass Community Research, Inc

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40504

Country

United States

Facility Name

Center for Rheumatology and Bone Research

City

Wheaton

State/Province

Maryland

ZIP/Postal Code

20902

Country

United States

Facility Name

M3-Emerging Medical Research, LLC

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27704

Country

United States

Facility Name

Paramount Medical Research and Consulting, LLC

City

Middleburg Heights

State/Province

Ohio

ZIP/Postal Code

44130

Country

United States

Facility Name

Oregon Health & Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Altoona Center For Clinical Research

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology

City

Summerville

State/Province

South Carolina

ZIP/Postal Code

29486

Country

United States

Facility Name

Precision Comprehensive Clinical Research Solutions

City

Colleyville

State/Province

Texas

ZIP/Postal Code

76034

Country

United States

Facility Name

Adriana Pop-Moody MD - Clinic PA

City

Corpus Christi

State/Province

Texas

ZIP/Postal Code

78404

Country

United States

Facility Name

Metroplex Clinical Research Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Clinical Research Unit

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Investigational Drug Services

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Memorial Hermann Hospital Imaging

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Southwest Rheumatology Research LLC

City

Mesquite

State/Province

Texas

ZIP/Postal Code

75150

Country

United States

Facility Name

Trinity Universal Research Associates, Inc.

City

Plano

State/Province

Texas

ZIP/Postal Code

75024

Country

United States

Facility Name

Advanced Rheumatology of Houston

City

The Woodlands

State/Province

Texas

ZIP/Postal Code

77382

Country

United States

Facility Name

Arthritis Northwest, PLLC

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

Pacific Radiology,

City

Maroochydore

State/Province

Queensland

ZIP/Postal Code

4558

Country

Australia

Facility Name

Rheumatology Research Unit Sunshine Coast

City

Maroochydore

State/Province

Queensland

ZIP/Postal Code

4558

Country

Australia

Facility Name

Emeritus Research Pty. Ltd.

City

Camberwell

State/Province

Victoria

ZIP/Postal Code

3124

Country

Australia

Facility Name

Melbourne Radiology Clinic

City

East Melbourne

State/Province

Victoria

ZIP/Postal Code

3002

Country

Australia

Facility Name

SKG Radiology

City

Subiaco

State/Province

Western Australia

ZIP/Postal Code

6008

Country

Australia

Facility Name

Western Cardiology

City

Subiaco

State/Province

Western Australia

ZIP/Postal Code

6008

Country

Australia

Facility Name

RK Will Pty Ltd

City

Victoria Park

State/Province

Western Australia

ZIP/Postal Code

6100

Country

Australia

Facility Name

Multiprofile Hospital for active treatment "Kaspela" EOOD

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Diagnostic-Consulting Center XVII - Sofia

City

Sofia

ZIP/Postal Code

1505

Country

Bulgaria

Facility Name

Medical Centre Synexus Sofia EOOD

City

Sofia

ZIP/Postal Code

1784

Country

Bulgaria

Facility Name

Centre de Recherche Musculo-Squelettique

City

Trois-Rivieres

State/Province

Quebec

ZIP/Postal Code

G8Z 1Y2

Country

Canada

Facility Name

G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.

City

Quebec

ZIP/Postal Code

G1V 3M7

Country

Canada

Facility Name

Guangdong Provincial People's Hospital

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510080

Country

China

Facility Name

The Third Affiliated Hospital, Sun Yat-Sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510630

Country

China

Facility Name

The Second Affiliated Hospital of Zhejiang University School of Medicine

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

Facility Name

The First Affiliated Hosptial of Wenzhou Medical University

City

Wenzhou

State/Province

Zhejiang

ZIP/Postal Code

325000

Country

China

Facility Name

Rheumatology and Immunology Department, Shanghai Changzheng Hospital

City

Shanghai

ZIP/Postal Code

200003

Country

China

Facility Name

Lekarna Rezidence Nova Karolina

City

Ostrava

ZIP/Postal Code

702 00

Country

Czechia

Facility Name

CCBR Ostrava s.r.o.

City

Ostrava

ZIP/Postal Code

70200

Country

Czechia

Facility Name

BENU Lekarna

City

Pardubice

ZIP/Postal Code

530 02

Country

Czechia

Facility Name

CCR, Czech a.s.

City

Pardubice

ZIP/Postal Code

530 02

Country

Czechia

Facility Name

Lekarna Hradebni, s.r.o.

City

Uherske Hradiste

ZIP/Postal Code

686 01

Country

Czechia

Facility Name

Uherskohradistska nemocnice, a.s.

City

Uherske Hradiste

ZIP/Postal Code

686 06

Country

Czechia

Facility Name

Medical Plus s.r.o.

City

Uherske Hradiste

ZIP/Postal Code

68601

Country

Czechia

Facility Name

CHRU de Tours, Hopital Trousseau

City

TOURS Cedex 9

ZIP/Postal Code

37044

Country

France

Facility Name

Qualiclinic K ft

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Pest megyei Flór Ferenc Kórház, Reumatológia-és Fizioterápiás Osztály

City

Kistarcsa

ZIP/Postal Code

2143

Country

Hungary

Facility Name

VITAL MEDICAL CENTER (VITÁL-MEDICINA Kft.)

City

Veszprém

ZIP/Postal Code

8200

Country

Hungary

Facility Name

Barzilai Medical Center

City

Ashkelon

ZIP/Postal Code

7830604

Country

Israel

Facility Name

Chonnam National University Hospital

City

Gwangju

ZIP/Postal Code

61469

Country

Korea, Republic of

Facility Name

Inha University Hospital

City

Incheon

ZIP/Postal Code

22332

Country

Korea, Republic of

Facility Name

Hanyang University Seoul Hospital

City

Seoul

ZIP/Postal Code

04763

Country

Korea, Republic of

Facility Name

Geo Medical Sp. z.o.o Szpital Geo Medical

City

Katowice

ZIP/Postal Code

40-042

Country

Poland

Facility Name

Moja Przychodnia

City

Katowice

ZIP/Postal Code

40-057

Country

Poland

Facility Name

C.M. Silmedic Sp. z o.o.

City

Katowice

ZIP/Postal Code

40-282

Country

Poland

Facility Name

Malopolskie Badania Kliniczne Sp. z o.o. s.k.

City

Krakow

ZIP/Postal Code

30-040

Country

Poland

Facility Name

Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA

City

Krakow

ZIP/Postal Code

30-053

Country

Poland

Facility Name

Centrum Medyczne Plejady

City

Krakow

ZIP/Postal Code

30-363

Country

Poland

Facility Name

Centrum Medyczne LUX MED

City

Krakow

ZIP/Postal Code

30-415

Country

Poland

Facility Name

Malopolskie Centrum Medyczne S.C.

City

Krakow

ZIP/Postal Code

30-510

Country

Poland

Facility Name

Szpital Uniwersytecki w Krakowie, Zaklad Radiologii

City

Krakow

ZIP/Postal Code

31-066

Country

Poland

Facility Name

Top Medical

City

Lublin

ZIP/Postal Code

20-601

Country

Poland

Facility Name

Zespol Poradni Specjalistycznych REUMED, Wallenroda Filia nr 1

City

Lublin

ZIP/Postal Code

20-607

Country

Poland

Facility Name

NZOZ JAMED Pracownia Rentgenowska Jerema Antoszewski

City

Poznan

ZIP/Postal Code

61-397

Country

Poland

Facility Name

Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj

City

Poznan

ZIP/Postal Code

61-397

Country

Poland

Facility Name

Klinika Alfa

City

Sochaczew

ZIP/Postal Code

96-500

Country

Poland

Facility Name

RCMed Oddzial Sochaczew

City

Sochaczew

ZIP/Postal Code

96-500

Country

Poland

Facility Name

Szpital Powiatowy w Sochaczewie

City

Sochaczew

ZIP/Postal Code

96-500

Country

Poland

Facility Name

Szpital Sw. Elzbiety, Mokotowskie Centrum Medyczne, Zaklad Diagnostyki

City

Warszawa

ZIP/Postal Code

02-616

Country

Poland

Facility Name

"Reumatika - Centrum Reumatologii" NZOZ

City

Warszawa

ZIP/Postal Code

02-691

Country

Poland

Facility Name

Centrum Medyczne Oporow

City

Wroclaw

ZIP/Postal Code

52-416

Country

Poland

Facility Name

Centrum Medyczne Medix

City

Wroclaw

ZIP/Postal Code

53-413

Country

Poland

Facility Name

Limited Liability Company Medical Center "Rheuma-Med"

City

Kemerovo

ZIP/Postal Code

650070

Country

Russian Federation

Facility Name

State Budgetary Healthcare Institution "Orenburg Regional Clinical Hospital"

City

Orenburg

ZIP/Postal Code

460018

Country

Russian Federation

Facility Name

Limited Liability Company "Sanavita"

City

Saint-Petersburg

ZIP/Postal Code

195257

Country

Russian Federation

Facility Name

State Healthcare Institution "Regional Clinical Hospital"

City

Saratov

ZIP/Postal Code

410053

Country

Russian Federation

Facility Name

RSBHI "Smolensk Regional Clinical Hospital"

City

Smolensk

ZIP/Postal Code

214018

Country

Russian Federation

Facility Name

Limited Liability Company "BioMed"

City

Vladimir

ZIP/Postal Code

600005

Country

Russian Federation

Facility Name

Ankara Universitesi Tip Fakultesi Ibn-i Sina Hastanesi

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Ankara Universitesi Tip Fakultesi, Ibn-i Sina Hastanesi

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Hacettepe Universitesi Tip Fakultesi, Ic Hastaliklari Anabilim

City

Ankara

ZIP/Postal Code

06230

Country

Turkey

Facility Name

Istanbul Universitesi Istanbul Tip Fakultesi, Ic Hastaliklari

City

Istanbul

ZIP/Postal Code

34093

Country

Turkey

Facility Name

Istanbul Universitesi Istanbul Tip Fakultesi

City

Istanbul

ZIP/Postal Code

34093

Country

Turkey

Facility Name

Marmara Univ. Istanbul Pendik Egitim ve Arastirma Hastanesi

City

Istanbul

ZIP/Postal Code

34899

Country

Turkey

Facility Name

Izmir Katip Celebi Univ Ataturk Egitim ve Arastirma Hastanesi

City

Izmir

ZIP/Postal Code

35360

Country

Turkey

Facility Name

Izmir Katip Celebi Univ. Ataturk Egitim ve Arastirma Hastanesi

City

Izmir

ZIP/Postal Code

35360

Country

Turkey

Facility Name

Kyiv City Clinical Hospital # 3, Rheumatology Department

City

Kyiv

ZIP/Postal Code

02125

Country

Ukraine

Facility Name

Lviv Communal Clinical Hospital #4, Rheumatology department

City

Lviv

ZIP/Postal Code

79011

Country

Ukraine

Facility Name

Military-Medical Clinical Center (Clinical Hospital with 200 beds) of State Border Guard Service of

City

Lviv

ZIP/Postal Code

79014

Country

Ukraine

Facility Name

Ternopil University Hospital, Department of Rheumatology,

City

Ternopil

ZIP/Postal Code

46002

Country

Ukraine

Facility Name

Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrohov, rheumatology department,

City

Vinnytsia

ZIP/Postal Code

21018

Country

Ukraine

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

IPD Sharing URL

https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Citations:

PubMed Identifier

36138330

Citation

Cella D, Lenderking WR, Chongpinitchai P, Bushmakin AG, Dina O, Wang L, Cappelleri JC, Navarro-Compan V. Functional Assessment of Chronic Illness Therapy-Fatigue is a reliable and valid measure in patients with active ankylosing spondylitis. J Patient Rep Outcomes. 2022 Sep 23;6(1):100. doi: 10.1186/s41687-022-00508-0.

Results Reference

derived

PubMed Identifier

35654457

Citation

Navarro-Compan V, Wei JC, Van den Bosch F, Magrey M, Wang L, Fleishaker D, Cappelleri JC, Wang C, Wu J, Dina O, Fallon L, Strand V. Effect of tofacitinib on pain, fatigue, health-related quality of life and work productivity in patients with active ankylosing spondylitis: results from a phase III, randomised, double-blind, placebo-controlled trial. RMD Open. 2022 Jun;8(2):e002253. doi: 10.1136/rmdopen-2022-002253.

Results Reference

derived

PubMed Identifier

33906853

Citation

Deodhar A, Sliwinska-Stanczyk P, Xu H, Baraliakos X, Gensler LS, Fleishaker D, Wang L, Wu J, Menon S, Wang C, Dina O, Fallon L, Kanik KS, van der Heijde D. Tofacitinib for the treatment of ankylosing spondylitis: a phase III, randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2021 Aug;80(8):1004-1013. doi: 10.1136/annrheumdis-2020-219601. Epub 2021 Apr 27.

Results Reference

derived

Links:

URL

https://pmiform.com/clinical-trial-info-request?StudyID=A3921120

Description

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Learn more about this trial

Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)

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