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Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo (C-OPTIMISE)

Primary Purpose

Axial Spondyloarthrithis, Ankylosing Spondylitis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Certolizumab Pegol

Placebo

About this trial

This is an interventional treatment trial for Axial Spondyloarthrithis focused on measuring Axial Spondyloarthritis, axSpA, Ankylosing Spondylitis, Anti TNF-alpha, Certolizumab Pegol, Remission, Spondylarthropathies, Arthritis, Spinal Diseases, Immunosuppressive Agents

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Documented diagnosis of adult-onset axial SpondyloArthritis (axSpA) with at least 3 months' symptom duration and meet the Assessment of SpondyloArthritis International Society (ASAS) criteria for axSpA and symptom duration of less than 5 years prior to the participation of this study
Active disease at Screening as defined by
- Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥ 2.1
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4
- Spinal pain > 4 on a 0 to 10 Numerical Rating Scale (NRS) (from BASDAI Item 2)
- for modified New York (mNY) -negative subjects only: C-reactive Protein (CRP) > upper limit of normal (ULN) and/or current evidence for sacroiliitis on the Screening Magnetic Resonance Imaging (MRI)
Inadequate response to, or contraindication to, or intolerant to at least 2 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

Exclusion Criteria:

Presence of total Spinal Ankylosis ('bamboo spine')
Diagnosis of any other Inflammatory Arthritis
Prior treatment with any experimental biological agents for treatment of Axial SpondyloArthritis (SpA)
Exposure to more than 1 TNF-antagonist or primary failure to TNF antagonist therapy
History of or current chronic or recurrent infections
High risk of infection
Recent live vaccination
Concurrent malignancy or a history of malignancy
Class III or IV congestive heart failure - New York Heart Association (NYHA)
Demyelinating disease of the central nervous system
Female subjects who are breastfeeding, pregnant or plan to become pregnant during the study or within 3 months following the last dose of the investigational product
Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion in the study

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Other

Experimental

Placebo Comparator

Other

Arm Label

Open-label Certolizumab Pegol

Double-blind Certolizumab Pegol 200 mg Q2W

Double-blind Certolizumab Pegol 200 mg Q4W

Placebo

Placebo to CZP 200 mg Q2W escape

CZP 200 mg Q4W to CZP 200 mg Q2W escape

CZP 200 mg Q2W to CZP 200 mg Q2W escape

Arm Description

Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 to Week 48 (Part A). Subjects in sustained remission at Week 48 are eligible for randomization into Part B.

Certolizumab Pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards.

Certolizumab Pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP is not received, subjects receive one injection of Placebo to maintain the study blind.

One placebo injection is administered every 2 weeks from Week 48 onwards.

Subjects randomized to Placebo who meet flare criteria receive CZP 400 mg subcutaneous (sc) every 2 weeks (Q2W) for the first 3 visits after flare has been confirmed. After that, CZP 200 mg is given every 2 weeks in open-label fashion.

Subjects randomized to CZP 200 mg Q4W who meet flare criteria receive CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, subjects receive one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.

Subjects randomized to CZP 200 mg Q2W who meet flare criteria receive CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, subjects receive one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.

Outcomes

Primary Outcome Measures

Percentage of Participants in Part B Who Did Not Experienced a Flare

A participant was considered to have experienced a flare if the participant had an Ankylosing spondylitis disease activity score (ASDAS) greater or equal to (≥) 2.1 at 2 consecutive visits or an ASDAS greater than (>) 3.5 at any visit during Part B up until Week 96. A participant qualified for Part B only if he achieved sustained remission after 48 weeks of Open-Label certolizumab pegol (CZP) treatment. Sustained remission was achieved when a participant had an ASDAS less than (<) 1.3 at Week 32 or Week 36 (if ASDAS < 1.3 at Week 32, it must have been < 2.1 at Week 36; if ASDAS < 2.1 at Week 32, it must have been < 1.3 at Week 36) and an ASDAS < 1.3 at Week 48. Missing data were handled using non-response imputation (NRI) methods.

Secondary Outcome Measures

Percentage of Participants Achieving Sustained Remission at Week 48 in Part A

Sustained remission was achieved when a participant had an ASDAS less than (<) 1.3 at Week 32 or Week 36 (if ASDAS < 1.3 at Week 32, it must have been < 2.1 at Week 36; if ASDAS < 2.1 at Week 32, it must have been < 1.3 at Week 36) and an ASDAS < 1.3 at Week 48. Missing data were handled using non-response imputation (NRI) methods.

Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Week 48 in Part A

The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units). Disease activity was measured by categorical response variables: ASDAS-Inactive Disease (ASDAS-ID): ASDAS < 1.3 ASDAS-Moderate Disease (ASDAS-MD): ASDAS ≥ 1.3, < 2.1 ASDAS-High Disease activity (ASDAS-HD): ASDAS ≥ 2.1, ≤ 3.5 ASDAS-very High Disease activity (ASDAS-vHD): ASDAS > 3.5 Missing data were handled using last observation carried forward (LOCF) methods.

Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Clinical Improvement Categories at Week 48 in Part A

The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units). ASDAS improvement was measured by binary response variables: ASDAS-CII: ASDAS reduction (improvement) of ≥ 1.1 relative to Baseline ASDAS-MI: ASDAS reduction (improvement) of ≥ 2.0 relative to Baseline Missing data were handled using non-response imputation (NRI) methods.

Time to Flare in Part B

For those who met the criteria for flare (see primary efficacy variable), the time to flare was the length in days from randomization in Part B until the visit at which the criteria for flare were met. Participants who discontinued the study without meeting the criteria for flare were counted as experiencing a flare at the time of their last study visit. The time to flare was analyzed using Kaplan-Meier methods. If Kaplan-Meier Estimate was NA for all estimates then more than 75 % failed to meet the flare condition. Missing data were handled using non-response imputation (NRI) methods.

Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Week 96 in Part B

Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Clinical Improvement Categories at Week 96 in Part B

The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units). ASDAS improvement was measured by binary response variables: ASDAS-CII: ASDAS reduction (improvement) of ≥ 1.1 relative to Baseline ASDAS-MI: ASDAS reduction (improvement) of ≥ 2.0 relative to Baseline Missing data were handled using non-response imputation (NRI) methods.

Percentage of Participants With Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at Week 96 in Part B

The ASAS20 response was defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and absence of deterioration in the potential remaining domain [deterioration was defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit]. Missing data were handled using non-response imputation (NRI) methods.

Percentage of Participants With Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at Week 96 in Part B

The ASAS40 response was defined as a relative improvement of at least 40 % and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain. Missing data were handled using non-response imputation (NRI) methods.

Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) 5/6 Response Criteria Response at Week 96 in Part B

The ASAS 5/6 response was defined as achieving at least 20 % improvement in 5 of 6 domains, including the 4 domains defined for ASAS20 as well as spinal mobility (lateral spinal flexion) and C-reactive Protein (CRP). Missing data were handled using non-response imputation (NRI) methods.

Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) Partial Remission (PR) Response Criteria Response at Week 96 in Part B

The ASAS partial remission (PR) response was defined as a score of ≤ 2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS20. Missing data were handled using non-response imputation (NRI) methods.

Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 96 in Part B

The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units). There is a minimum score of 0.636 for the total ASDAS score, but no defined upper score. Based on the formula even in the situation that the CRP is normal, any value below 4 is recorded as "below the limit of quantification" (BLQ) and a value of BLQ/2=2 was prespecified. This assumption is triggering the lowest possible value of 0.636. The change from Part B Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 96 in Part B

The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales (NRS) to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI scores ranges from 0 to 10, with lower scores indicating lower disease activity. The change from Part B Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 96 in Part B

The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 (Easy) to 10 (Impossible), with lower scores indicating better physical function. The change from Part B Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 96 in Part B

The BASMI is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 was calculated for each item based on the measurement. The mean of the sum of the 5 scores provided the total BASMI score, ranging from 0 to 10. The higher the BASMI score the more severe the patient's limitation of movement due to their axial spondyloarthritis (axSpA). The change from Part B Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response Criteria Response at Week 96 in Part B

The BASDAI50 response was defined as an improvement of at least 50 % in the BASDAI score relative to Baseline. Missing data were handled using non-response imputation (NRI) methods.

Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Week 96 in Part B

The SPARCC scoring method for lesions found on the Magnetic Resonance Imaging (MRI) is based on an abnormal increased signal on the Short-Tau-Inversion Recovery (STIR) sequence, representing bone marrow edema. Total Sacroiliac (SI) joint SPARCC score can range from 0 to 72 with higher scores indicating higher joint inflammation. The change from Part B Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Change From Baseline in Spine Ankylosing Spondylitis Spine Magnetic Resonance Imaging Score for Disease Activity (ASspIMRI-a) in the Berlin Modification Score at Week 96 in Part B

The Berlin modification of the ASspiMRI-a is a scoring system with a concentration on Short-Tau-Inversion Recovery (STIR) sequences without other fat saturation techniques. It quantifies changes in 23 Vertebral Units (VU) of the spine. Active inflammation was scored by grading the degree of bone marrow edema from 0 to 3 in 1 dimension on 1 or more consecutive slices that represent the highest level of inflammation in a particular VU. The change from Part B Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Escape Week 12 for Participants Who Experienced a Flare in Part B

Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Clinical Improvement Categories at Escape Week 12 for Participants Who Experienced a Flare in Part B

The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units). ASDAS improvement was measured by binary response variables: ASDAS-CII: ASDAS reduction (improvement) of ≥ 1.1 relative to Baseline ASDAS-MI: ASDAS reduction (improvement) of ≥ 2.0 relative to Baseline

Percentage of Participants With Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at Escape Week 12 for Participants Who Experienced a Flare in Part B

Percentage of Participants With Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at Escape Week 12 for Participants Who Experienced a Flare in Part B

Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) 5/6 Response Criteria Response at Escape Week 12 for Participants Who Experienced a Flare in Part B

Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) Partial Remission (PR) Response Criteria Response at Escape Week 12 for Participants Who Experienced a Flare in Part B

The ASAS partial remission (PR) response was defined as a score of ≤ 2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS20.

Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Escape Week 12 for Participants Who Experienced a Flare in Part B

The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units). There is a minimum score of 0.636 for the total ASDAS score, but no defined upper score. Based on the formula even in the situation that the CRP is normal, any value below 4 is recorded as "below the limit of quantification" (BLQ) and a value of BLQ/2=2 was prespecified. This assumption is triggering the lowest possible value of 0.636. The change from Part B Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Escape Week 12 for Participants Who Experienced a Flare in Part B

The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales (NRS) to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI scores ranges from 0 to 10, with lower scores indicating lower disease activity. The change from flare Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Escape Week 12 for Participants Who Experienced a Flare in Part B

The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 (Easy) to 10 (Impossible), with lower scores indicating better physical function. The change from flare Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Escape Week 12 for Participants Who Experienced a Flare in Part B

The BASMI is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 was calculated for each item based on the measurement. The mean of the sum of the 5 scores provided the total BASMI score, ranging from 0 to 10. The higher the BASMI score the more severe the patient's limitation of movement due to their axial spondyloarthritis (axSpA). The change from flare Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Escape Week 12 for Participants Who Experienced a Flare in Part B

The SPARCC scoring method for lesions found on the Magnetic Resonance Imaging (MRI) is based on an abnormal increased signal on the Short-Tau-Inversion Recovery (STIR) sequence, representing bone marrow edema. Total Sacroiliac (SI) joint SPARCC score can range from 0 to 72 with higher scores indicating higher joint inflammation. The change from flare Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Change From Baseline in Spine Ankylosing Spondylitis Spine Magnetic Resonance Imaging Score for Activity (ASspIMRI-a) in the Berlin Modification Score at Escape Week 12 for Participants Who Experienced a Flare in Part B

The Berlin modification of the ASspiMRI-a is a scoring system with a concentration on Short-Tau-Inversion Recovery (STIR) sequences without other fat saturation techniques. It quantifies changes in 23 Vertebral Units (VU) of the spine. Active inflammation was scored by grading the degree of bone marrow edema from 0 to 3 in 1 dimension on 1 or more consecutive slices that represent the highest level of inflammation in a particular VU. The change from flare Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Certolizumab Pegol (CZP) Plasma Concentration During the Study

CZP plasma concentration was measured in micrograms per milliliter (μg/mL). Blood sample measurements that were deemed to be below the level of quantification, were set to half the lower level of quantification (LLOQ) for analysis purposes. Summary statistics were only displayed if at least two-thirds of the values were above the LLOQ and if n was greater or equal to (>=) 4. The primary purpose of the study was to evaluate treatment options for axSpA patients after being in sustained remission. Hence, one of the objectives was to evaluate the PK of these patients. The CZP plasma concentration of the patients that did not reach sustained remission were therefore not analysed, and the Pharmacokinetic Set A as described in the protocol was removed from the SAP.

Percentage of Participants With Positive Anti-certolizumab Pegol-antibody Levels in Plasma During the Study

Treatment emergent ADAb status positive was defined as either baseline ADAb negative subjects having at least one ADAb confirmed positive sample post baseline or baseline ADAb positive subjects with at least one post baseline sample with >= minimum significant ratio (MSR) increase from baseline on CZP treatment. Once determined positive, the highest titer during Part A and Part B (including Escape and Safety Follow up) was used to categorize the subject. The primary purpose of the study was to evaluate treatment options for axSpA patients after being in sustained remission. Hence, one of the objectives was to evaluate the immunogenicity of these patients. The ADAb titer of the patients that did not reach sustained remission were therefore not analysed, and the Pharmacokinetic Set A as described in the protocol was removed from the SAP.

Percentage of Participants With at Least One Adverse Event (AE) During Part A of the Study

An AE was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Percentage of Participants With at Least One Adverse Event (AE) During Part B of the Study

Percentage of Participants With at Least One Adverse Event (AE) and Who Experienced a Flare During Part B of the Study

Full Information

NCT ID

NCT02505542

First Posted

July 16, 2015

Last Updated

November 26, 2020

Sponsor

UCB BIOSCIENCES GmbH

Collaborators

Parexel

1. Study Identification

Unique Protocol Identification Number

NCT02505542

Brief Title

Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo

Acronym

C-OPTIMISE

Official Title

A Multicenter, Open-label (Part A) Followed by a Randomized, Double-blind, Parallel-group, Placebo Controlled Study (Part B) to Evaluate Maintenance of Remission in Subjects With Active Axial Spondyloarthritis (axSpA) Receiving Either Certolizumab Pegol 200 mg Q2W or 200 mg Q4W as Compared to Placebo

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

July 2015 (Actual)

Primary Completion Date

February 2019 (Actual)

Study Completion Date

April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UCB BIOSCIENCES GmbH

Collaborators

Parexel

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Patients receive study drug for one year (Part A). If, after the initial run-in phase, a sustained remission is reached they will be randomly split into one of three dose groups for another year (Part B). The maintenance of the sustained remission will be analyzed.

6. Conditions and Keywords

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

Axial Spondyloarthrithis, Ankylosing Spondylitis

Keywords

Axial Spondyloarthritis, axSpA, Ankylosing Spondylitis, Anti TNF-alpha, Certolizumab Pegol, Remission, Spondylarthropathies, Arthritis, Spinal Diseases, Immunosuppressive Agents

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

736 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Open-label Certolizumab Pegol

Arm Type

Other

Arm Description

Arm Title

Double-blind Certolizumab Pegol 200 mg Q2W

Arm Type

Experimental

Arm Description

Certolizumab Pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards.

Arm Title

Double-blind Certolizumab Pegol 200 mg Q4W

Arm Type

Experimental

Arm Description

Certolizumab Pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP is not received, subjects receive one injection of Placebo to maintain the study blind.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

One placebo injection is administered every 2 weeks from Week 48 onwards.

Arm Title

Placebo to CZP 200 mg Q2W escape

Arm Type

Other

Arm Description

Arm Title

CZP 200 mg Q4W to CZP 200 mg Q2W escape

Arm Type

Other

Arm Description

Arm Title

CZP 200 mg Q2W to CZP 200 mg Q2W escape

Arm Type

Other

Arm Description

Intervention Type

Biological

Intervention Name(s)

Certolizumab Pegol

Other Intervention Name(s)

Cimzia, CDP870

Intervention Description

Active substance: Certolizumab Pegol Pharmaceutical form: Prefilled syringe Concentration: 200 mg / ml Route of Administration: Subcutaneous injection

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Active substance: Placebo Pharmaceutical form: Prefilled syringe Concentration: 0.9 % Saline Route of Administration: Subcutaneous injection

Primary Outcome Measure Information:

Title

Percentage of Participants in Part B Who Did Not Experienced a Flare

Description

Time Frame

From Week 48 to Week 96

Secondary Outcome Measure Information:

Title

Percentage of Participants Achieving Sustained Remission at Week 48 in Part A

Description

Time Frame

Week 48

Title

Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Week 48 in Part A

Description

Time Frame

Week 48

Title

Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Clinical Improvement Categories at Week 48 in Part A

Description

The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units). ASDAS improvement was measured by binary response variables: ASDAS-CII: ASDAS reduction (improvement) of ≥ 1.1 relative to Baseline ASDAS-MI: ASDAS reduction (improvement) of ≥ 2.0 relative to Baseline Missing data were handled using non-response imputation (NRI) methods.

Time Frame

Week 48

Title

Time to Flare in Part B

Description

Time Frame

From Week 48 to Week 96

Title

Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Week 96 in Part B

Description

Time Frame

Week 96

Title

Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Clinical Improvement Categories at Week 96 in Part B

Description

The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units). ASDAS improvement was measured by binary response variables: ASDAS-CII: ASDAS reduction (improvement) of ≥ 1.1 relative to Baseline ASDAS-MI: ASDAS reduction (improvement) of ≥ 2.0 relative to Baseline Missing data were handled using non-response imputation (NRI) methods.

Time Frame

Week 96

Title

Percentage of Participants With Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at Week 96 in Part B

Description

Time Frame

Week 96

Title

Percentage of Participants With Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at Week 96 in Part B

Description

Time Frame

Week 96

Title

Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) 5/6 Response Criteria Response at Week 96 in Part B

Description

Time Frame

Week 96

Title

Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) Partial Remission (PR) Response Criteria Response at Week 96 in Part B

Description

Time Frame

Week 96

Title

Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 96 in Part B

Description

The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units). There is a minimum score of 0.636 for the total ASDAS score, but no defined upper score. Based on the formula even in the situation that the CRP is normal, any value below 4 is recorded as "below the limit of quantification" (BLQ) and a value of BLQ/2=2 was prespecified. This assumption is triggering the lowest possible value of 0.636. The change from Part B Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Time Frame

From Week 48 to Week 96

Title

Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 96 in Part B

Description

Time Frame

From Week 48 to Week 96

Title

Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 96 in Part B

Description

Time Frame

From Week 48 to Week 96

Title

Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 96 in Part B

Description

Time Frame

From Week 48 to Week 96

Title

Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response Criteria Response at Week 96 in Part B

Description

The BASDAI50 response was defined as an improvement of at least 50 % in the BASDAI score relative to Baseline. Missing data were handled using non-response imputation (NRI) methods.

Time Frame

Week 96

Title

Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Week 96 in Part B

Description

Time Frame

From Week 48 to Week 96

Title

Change From Baseline in Spine Ankylosing Spondylitis Spine Magnetic Resonance Imaging Score for Disease Activity (ASspIMRI-a) in the Berlin Modification Score at Week 96 in Part B

Description

Time Frame

From Week 48 to Week 96

Title

Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Escape Week 12 for Participants Who Experienced a Flare in Part B

Description

Time Frame

Escape Week 12

Title

Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Clinical Improvement Categories at Escape Week 12 for Participants Who Experienced a Flare in Part B

Description

The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units). ASDAS improvement was measured by binary response variables: ASDAS-CII: ASDAS reduction (improvement) of ≥ 1.1 relative to Baseline ASDAS-MI: ASDAS reduction (improvement) of ≥ 2.0 relative to Baseline

Time Frame

Escape Week 12

Title

Percentage of Participants With Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at Escape Week 12 for Participants Who Experienced a Flare in Part B

Description

Time Frame

Escape Week 12

Title

Percentage of Participants With Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at Escape Week 12 for Participants Who Experienced a Flare in Part B

Description

Time Frame

Escape Week 12

Title

Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) 5/6 Response Criteria Response at Escape Week 12 for Participants Who Experienced a Flare in Part B

Description

Time Frame

Escape Week 12

Title

Description

The ASAS partial remission (PR) response was defined as a score of ≤ 2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS20.

Time Frame

Escape Week 12

Title

Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Escape Week 12 for Participants Who Experienced a Flare in Part B

Description

The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units). There is a minimum score of 0.636 for the total ASDAS score, but no defined upper score. Based on the formula even in the situation that the CRP is normal, any value below 4 is recorded as "below the limit of quantification" (BLQ) and a value of BLQ/2=2 was prespecified. This assumption is triggering the lowest possible value of 0.636. The change from Part B Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Time Frame

From time of flare to Escape Week 12

Title

Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Escape Week 12 for Participants Who Experienced a Flare in Part B

Description

The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales (NRS) to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI scores ranges from 0 to 10, with lower scores indicating lower disease activity. The change from flare Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Time Frame

From time of flare to Escape Week 12

Title

Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Escape Week 12 for Participants Who Experienced a Flare in Part B

Description

The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 (Easy) to 10 (Impossible), with lower scores indicating better physical function. The change from flare Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Time Frame

From time of flare to Escape Week 12

Title

Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Escape Week 12 for Participants Who Experienced a Flare in Part B

Description

The BASMI is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 was calculated for each item based on the measurement. The mean of the sum of the 5 scores provided the total BASMI score, ranging from 0 to 10. The higher the BASMI score the more severe the patient's limitation of movement due to their axial spondyloarthritis (axSpA). The change from flare Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Time Frame

From time of flare to Escape Week 12

Title

Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Escape Week 12 for Participants Who Experienced a Flare in Part B

Description

The SPARCC scoring method for lesions found on the Magnetic Resonance Imaging (MRI) is based on an abnormal increased signal on the Short-Tau-Inversion Recovery (STIR) sequence, representing bone marrow edema. Total Sacroiliac (SI) joint SPARCC score can range from 0 to 72 with higher scores indicating higher joint inflammation. The change from flare Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Time Frame

From time of flare to Escape Week 12

Title

Description

The Berlin modification of the ASspiMRI-a is a scoring system with a concentration on Short-Tau-Inversion Recovery (STIR) sequences without other fat saturation techniques. It quantifies changes in 23 Vertebral Units (VU) of the spine. Active inflammation was scored by grading the degree of bone marrow edema from 0 to 3 in 1 dimension on 1 or more consecutive slices that represent the highest level of inflammation in a particular VU. The change from flare Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Time Frame

From time of flare to Escape Week 12

Title

Certolizumab Pegol (CZP) Plasma Concentration During the Study

Description

Time Frame

From Week 0 until the Safety Follow-up Visit (10 weeks after the last dose of study medication)

Title

Percentage of Participants With Positive Anti-certolizumab Pegol-antibody Levels in Plasma During the Study

Description

Time Frame

From Week 0 until the Safety Follow-up Visit (10 weeks after the last dose of study medication)

Title

Percentage of Participants With at Least One Adverse Event (AE) During Part A of the Study

Description

Time Frame

From Screening Period (Week -5 to Week -1) until Week 48

Title

Percentage of Participants With at Least One Adverse Event (AE) During Part B of the Study

Description

Time Frame

From Week 0 until the Safety Follow-up Visit (10 weeks after the last dose of study medication)

Title

Percentage of Participants With at Least One Adverse Event (AE) and Who Experienced a Flare During Part B of the Study

Description

Time Frame

From time of flare to Escape Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Documented diagnosis of adult-onset axial SpondyloArthritis (axSpA) with at least 3 months' symptom duration and meet the Assessment of SpondyloArthritis International Society (ASAS) criteria for axSpA and symptom duration of less than 5 years prior to the participation of this study Active disease at Screening as defined by Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥ 2.1 Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 Spinal pain > 4 on a 0 to 10 Numerical Rating Scale (NRS) (from BASDAI Item 2) for modified New York (mNY) -negative subjects only: C-reactive Protein (CRP) > upper limit of normal (ULN) and/or current evidence for sacroiliitis on the Screening Magnetic Resonance Imaging (MRI) Inadequate response to, or contraindication to, or intolerant to at least 2 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Exclusion Criteria: Presence of total Spinal Ankylosis ('bamboo spine') Diagnosis of any other Inflammatory Arthritis Prior treatment with any experimental biological agents for treatment of Axial SpondyloArthritis (SpA) Exposure to more than 1 TNF-antagonist or primary failure to TNF antagonist therapy History of or current chronic or recurrent infections High risk of infection Recent live vaccination Concurrent malignancy or a history of malignancy Class III or IV congestive heart failure - New York Heart Association (NYHA) Demyelinating disease of the central nervous system Female subjects who are breastfeeding, pregnant or plan to become pregnant during the study or within 3 months following the last dose of the investigational product Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion in the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

UCB Cares

Organizational Affiliation

+1 844 599 2273(UCB)

Official's Role

Study Director

Facility Information:

Facility Name

As0005 2313

City

Glendale

State/Province

Arizona

ZIP/Postal Code

85304

Country

United States

Facility Name

As0005 2316

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85202

Country

United States

Facility Name

As0005 2314

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85037

Country

United States

Facility Name

As0005 2317

City

Sun City

State/Province

Arizona

ZIP/Postal Code

85351

Country

United States

Facility Name

As0005 2307

City

Palm Desert

State/Province

California

ZIP/Postal Code

92260

Country

United States

Facility Name

As0005 2310

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Facility Name

As0005 2305

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

As0005 2308

City

Denver

State/Province

Colorado

ZIP/Postal Code

80230

Country

United States

Facility Name

As0005 2302

City

Brandon

State/Province

Florida

ZIP/Postal Code

33511

Country

United States

Facility Name

As0005 2321

City

Hagerstown

State/Province

Maryland

ZIP/Postal Code

21742

Country

United States

Facility Name

As0005 2312

City

Minot

State/Province

North Dakota

ZIP/Postal Code

58701

Country

United States

Facility Name

As0005 2323

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73101

Country

United States

Facility Name

As0005 2311

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

As0005 2315

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38305

Country

United States

Facility Name

As0005 2303

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

As0005 2318

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

As0005 1006

City

Genk

Country

Belgium

Facility Name

As0005 1001

City

Gent

Country

Belgium

Facility Name

As0005 1004

City

Merksem

Country

Belgium

Facility Name

As0005 1003

City

Mons

Country

Belgium

Facility Name

As0005 1109

City

Pleven

Country

Bulgaria

Facility Name

As0005 1103

City

Plovdiv

Country

Bulgaria

Facility Name

As0005 1106

City

Plovdiv

Country

Bulgaria

Facility Name

As0005 1111

City

Ruse

Country

Bulgaria

Facility Name

As0005 1110

City

Sevlievo

Country

Bulgaria

Facility Name

As0005 1101

City

Sofia

Country

Bulgaria

Facility Name

As0005 1108

City

Sofia

Country

Bulgaria

Facility Name

As0005 1308

City

Brno

Country

Czechia

Facility Name

As0005 1309

City

Bruntal

Country

Czechia

Facility Name

As0005 1301

City

Kladno

Country

Czechia

Facility Name

As0005 1307

City

Ostrava

Country

Czechia

Facility Name

As0005 1303

City

Pardubice

Country

Czechia

Facility Name

As0005 1305

City

Praha 11

Country

Czechia

Facility Name

As0005 1306

City

Praha 2

Country

Czechia

Facility Name

As0005 1314

City

Praha 3

Country

Czechia

Facility Name

As0005 1302

City

Praha 4

Country

Czechia

Facility Name

As0005 1310

City

Praha 5

Country

Czechia

Facility Name

As0005 1311

City

Praha 5

Country

Czechia

Facility Name

As0005 1313

City

Uherske Hradiste

Country

Czechia

Facility Name

As0005 1304

City

Zlin

Country

Czechia

Facility Name

As0005 1504

City

Montpellier

Country

France

Facility Name

As0005 1505

City

Orleans

Country

France

Facility Name

As0005 1501

City

Paris

Country

France

Facility Name

As0005 1503

City

Tours Cedex 9

Country

France

Facility Name

As0005 1406

City

Berlin

Country

Germany

Facility Name

As0005 1408

City

Berlin

Country

Germany

Facility Name

As0005 1410

City

Berlin

Country

Germany

Facility Name

As0005 1412

City

Berlin

Country

Germany

Facility Name

As0005 1413

City

Bochum

Country

Germany

Facility Name

As0005 1405

City

Erlangen

Country

Germany

Facility Name

As0005 1404

City

Frankfurt am Main

Country

Germany

Facility Name

As0005 1402

City

Hamburg

Country

Germany

Facility Name

As0006 1409

City

Herne

Country

Germany

Facility Name

As0005 1407

City

Koeln

Country

Germany

Facility Name

As0005 1403

City

Leipzig

Country

Germany

Facility Name

As0005 1705

City

Budapest

Country

Hungary

Facility Name

As0005 1710

City

Budapest

Country

Hungary

Facility Name

As0005 1704

City

Debrecen

Country

Hungary

Facility Name

As0005 1706

City

Miskolc

Country

Hungary

Facility Name

As0005 1711

City

Nyiregyhaza

Country

Hungary

Facility Name

As0005 1707

City

Szeged

Country

Hungary

Facility Name

As0005 1702

City

Szentes

Country

Hungary

Facility Name

As0005 1703

City

Szombathely

Country

Hungary

Facility Name

As0005 1701

City

Veszprem

Country

Hungary

Facility Name

As0005 2502

City

Amsterdam

Country

Netherlands

Facility Name

As0005 2503

City

Rotterdam

Country

Netherlands

Facility Name

As0005 2501

City

Sneek

Country

Netherlands

Facility Name

As0005 1806

City

Bialystok

Country

Poland

Facility Name

As0005 1805

City

Bydgoszcz

Country

Poland

Facility Name

As0005 1801

City

Elblag

Country

Poland

Facility Name

As0005 1802

City

Elblag

Country

Poland

Facility Name

As0005 1812

City

Krakow

Country

Poland

Facility Name

As0005 1808

City

Lodz

Country

Poland

Facility Name

As0005 1814

City

Lodz

Country

Poland

Facility Name

As0005 1803

City

Lublin

Country

Poland

Facility Name

As0005 1816

City

Ostrowiec Swietokrzyski

Country

Poland

Facility Name

As0005 1809

City

Poznan

Country

Poland

Facility Name

As0005 1813

City

Poznan

Country

Poland

Facility Name

As0005 1807

City

Torun

Country

Poland

Facility Name

As0005 1804

City

Warszawa

Country

Poland

Facility Name

As0005 1811

City

Warszawa

Country

Poland

Facility Name

As0005 1815

City

Warszawa

Country

Poland

Facility Name

As0005 1904

City

Braila

Country

Romania

Facility Name

As0005 1912

City

Brasov

Country

Romania

Facility Name

As0005 1902

City

Bucuresti

Country

Romania

Facility Name

As0005 1903

City

Bucuresti

Country

Romania

Facility Name

As0005 1913

City

Bucuresti

Country

Romania

Facility Name

As0005 1907

City

Cluj-Napoca

Country

Romania

Facility Name

As0005 1910

City

Iasi

Country

Romania

Facility Name

As0005 1911

City

Târgu-Mureş

Country

Romania

Facility Name

As0005 2403

City

Cordoba

Country

Spain

Facility Name

As0005 2404

City

Getafe

Country

Spain

Facility Name

As0005 2401

City

Madrid

Country

Spain

Facility Name

As0005 2402

City

Sevilla

Country

Spain

Facility Name

As0005 2205

City

Kaohsiung

Country

Taiwan

Facility Name

As0005 2201

City

Taichung

Country

Taiwan

Facility Name

As0005 2202

City

Taichung

Country

Taiwan

Facility Name

As0005 2203

City

Taipei

Country

Taiwan

Facility Name

As0005 2204

City

Taipei

Country

Taiwan

Facility Name

As0005 2206

City

Taipei

Country

Taiwan

Facility Name

As0005 2101

City

Ankara

Country

Turkey

Facility Name

As0005 2103

City

Edirne

Country

Turkey

Facility Name

As0005 2102

City

Gaziantep

Country

Turkey

Facility Name

As0005 2105

City

Istanbul

Country

Turkey

Facility Name

As0005 2106

City

Istanbul

Country

Turkey

Facility Name

As0005 2104

City

Izmir

Country

Turkey

Facility Name

As0005 1603

City

Leeds

Country

United Kingdom

Facility Name

As0005 1601

City

Norwich

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

32381562

Citation

Landewe RB, van der Heijde D, Dougados M, Baraliakos X, Van den Bosch FE, Gaffney K, Bauer L, Hoepken B, Davies OR, de Peyrecave N, Thomas K, Gensler LS. Maintenance of clinical remission in early axial spondyloarthritis following certolizumab pegol dose reduction. Ann Rheum Dis. 2020 Jul;79(7):920-928. doi: 10.1136/annrheumdis-2019-216839. Epub 2020 May 7. Erratum In: Ann Rheum Dis. 2020 Sep;79(9):e120.

Results Reference

background

PubMed Identifier

32529495

Citation

Landewe R, van der Heijde D, Dougados M, Baraliakos X, Van den Bosch F, Gaffney K, Bauer L, Hoepken B, de Peyrecave N, Thomas K, Gensler LS. Induction of Sustained Clinical Remission in Early Axial Spondyloarthritis Following Certolizumab Pegol Treatment: 48-Week Outcomes from C-OPTIMISE. Rheumatol Ther. 2020 Sep;7(3):581-599. doi: 10.1007/s40744-020-00214-7. Epub 2020 Jun 11.

Results Reference

derived

Links:

URL

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

Description

FDA Safety Alerts and Recalls

Learn more about this trial

Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo

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Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo (C-OPTIMISE)

Axial Spondyloarthrithis, Ankylosing Spondylitis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial