SpondyloarthropathiesPhase 3NCT01087762
Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis
A Phase 3 study testing CZP 200 mg Q2W and CZP 400 mg Q4W in people with Spondyloarthropathies, run by UCB BIOSCIENCES GmbH at 104 sites in 15 countries.
Trial summary
The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of two dose regimens of Certolizumab Pegol (CZP) in subjects with active axial Spondyloarthritis (axial SpA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondyloarthropathies
- What is being tested?
- CZP 200 mg Q2W and CZP 400 mg Q4W
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 325 participants
- Where
- 104 sitesin 15 countries
- Study dates
- Mar 2010to Aug 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented diagnosis of adult-onset axial Spondyloarthritis (SpA) of at least 3 months' duration as defined by the specified Assessment of Spondyloarthritis International Society (ASAS) criteria
- Active disease as defined by:
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4
- Back pain ≥ 4 on a 0 to 10 Neurobehavioral Rating Scale (NRS) (from BASDAI item 2)
- C-Reactive Protein (CRP) > ULN (Upper Limit of Normal) and/or current evidence (ie, within the last 3 months from Screening) for Sacroiliitis on Magnetic Resonance Imaging (MRI) as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria
- Intolerance to or inadequate response to at least 1 Nonsteroidal Anti-Inflammatory Drug (NSAID)
Who cannot join
- 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 to more than 2 previous biological agents for Axial Spondyloarthritis (SpA)
- History of or current chronic or recurrent infections
- High risk of infection
Show all 12Show fewer
- 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
Trial locations and contacts
104 sites in 15 countries.
104 sites in 15 countries
United States32 sites
963
Asheville, North Carolina
957
Aventura, Florida
961
Birmingham, Alabama
985
Brooklyn, New York
977
Cleveland, Ohio
975
Dallas, Texas
972
Duncansville, Pennsylvania
969
Eagan, Minnesota
965
Florissant, Missouri
984
Flowood, Mississippi
962
Fort Lauderdale, Florida
964
Hagerstown, Maryland
978
Houston, Texas
983
Houston, Texas
974
La Jolla, California
973
Los Angeles, California
951
Middleburg Heights, Ohio
970
Oklahoma City, Oklahoma
959
Orange Park, Florida
966
Palm Desert, California
954
Peoria, Arizona
990
Pinellas Park, Florida
982
Portland, Oregon
981
Salt Lake City, Utah
967
San Antonio, Texas
952
San Diego, California
971
Scottsdale, Arizona
968
Seattle, Washington
950
St Louis, Missouri
987
Tucson, Arizona
953
Tuscaloosa, Alabama
958
Vero Beach, Florida
Poland10 sites
458
Bialystok
452
Dąbrówka
455
Elblag
459
Gdanks
457
Krakow
450
Lublin
454
Poznan
453
Torun
456
Warsaw
462
Warsaw
Argentina9 sites
700
Buenos Aires
701
Buenos Aires
704
Buenos Aires
705
Córdoba
709
La Plata
706
Rosario
710
San Juan
702
San Miguel de Tucumán
708
San Miguel de Tucumán
Germany9 sites
257
Berlin
258
Berlin
255
Freiburg im Breisgau
254
Hamburg
250
Herne
253
Leipzig
260
München
263
München
256
Ratingen
France6 sites
200
Boulogne-Billan Court
201
Lille
205
Limoges
206
Montpellier
204
Paris
202
Tours
Canada5 sites
902
Sainte-Foy, Quebec
900
St. John's, Newfoundland and Labrador
907
Victoria, British Columbia
910
Windsor, Ontario
903
Winnipeg, Manitoba
About this study
Official title: Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis
The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of two dose regimens of Certolizumab Pegol (CZP) in subjects with active axial Spondyloarthritis (axial SpA).
- Conditions
- Spondyloarthropathies
- Being tested
- CZP 200 mg Q2W, CZP 400 mg Q4W, Placebo
- Keywords
- Certolizumab Pegol, Cimzia
- Medical subject headings
- Spondylarthropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CZP 200 mg Q2WBiological
Also called Cimzia, CZP, Certolizumab Pegol
200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
CZP 400 mg Q4WBiological
Also called Cimzia, CZP, Certolizumab Pegol
400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
PlaceboOther
Matching Placebo to CZP injection.
| Study group | Role | What they receive |
|---|---|---|
| CZP 200 mg Q2W | Experimental | Subjects received 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 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. Receives: Biological: CZP 200 mg Q2W; Other: Placebo |
| CZP 400 mg Q4W | Experimental | Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind. Receives: Biological: CZP 400 mg Q4W; Other: Placebo |
| Placebo | Placebo comparator | Matching Placebo to CZP injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.
After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg Q2W or CZP 400 mg Q4W. Receives: Other: Placebo |
| Placebo to CZP 200 mg escape on Week 16 | Other | Matching Placebo to CZP injections from Week 0 to Week 16. Subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16 and were treated with three loading doses of CZP 400 mg sc on Weeks 16, 18 and 20, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 22 onwards. Additionally, Placebo injections were administered as appropriate in order to maintain the study blind. Receives: Biological: CZP 200 mg Q2W; Other: Placebo |
| Placebo to CZP 400 mg escape on Week 16 | Other | Matching Placebo to CZP injections from Week 0 to Week 16. Subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16 and were treated with three loading doses of CZP 400 mg sc on Weeks 16, 18 and 20, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 24 onwards. Additionally, Placebo injections were administered as appropriate in order to maintain the study blind. Receives: Biological: CZP 400 mg Q4W; Other: Placebo |
| Placebo to CZP 200 mg on Week 24 | Other | Matching Placebo to CZP injections from Week 0 to Week 24. Three loading doses of CZP 400 mg sc were given on Weeks 24, 26 and 28, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 30 onwards. Additionally, Placebo injections were administered as appropriate in order to maintain the study blind. Receives: Biological: CZP 200 mg Q2W; Other: Placebo |
| Placebo to CZP 400 mg on Week 24 | Other | Matching Placebo to CZP injections from Week 0 to Week 24. Three loading doses of CZP 400 mg sc were given on Weeks 24, 26 and 28, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 32 onwards. Additionally, Placebo injections were administered as appropriate in order to maintain the study blind. Receives: Biological: CZP 400 mg Q4W; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 12
The ASAS20 is 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 following domains:
- Patient's Global Assessment of Disease Activity
- Pain assessment (total spinal pain)
- Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))
- Inflammation (the mean of the 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 is defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit).
Measured: Week 12
Secondary outcomes (9)
Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 24
The ASAS20 is 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 following domains:
- Patient's Global Assessment of Disease Activity
- Pain assessment (total spinal pain)
- Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))
- Inflammation (the mean of the 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 is defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit).
Measured: Week 24
Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 12
The BASFI assesses physical function in comprising 10 items relating to activities during the past week. Each item ranges from 0 ("Easy") to 10 ("Impossible"). The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function. A negative value in BASFI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Measured: From Baseline to Week 12
Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24
The BASFI assesses physical function in comprising 10 items relating to activities during the past week. Each item ranges from 0 ("Easy") to 10 ("Impossible"). The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function. A negative value in BASFI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Measured: From Baseline to Week 24
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12
The BASDAI is a validated self-reported instrument which consists of six 10 unit horizontal Numerical Rating Scales (NRSs) to measure severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration, respectively) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity. A negative value in BASDAI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Measured: From Baseline to Week 12
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24
The BASDAI is a validated self-reported instrument which consists of six 10 unit horizontal Numerical Rating Scales (NRSs) to measure severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration, respectively) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity. A negative value in BASDAI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Measured: From Baseline to Week 24
Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 12
The BASMI characterizes the spinal mobility of subjects with axial Spondyloarthritis (SpA) and Ankylosing Spondylitis (AS). It 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 is calculated for each item based on the measurement. The mean of the sum of the 5 scores provides the BASMI score. The higher the BASMI score the more severe the patient's limitation of movement due to their axial SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Measured: From Baseline to Week 12
Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 24
The BASMI characterizes the spinal mobility of subjects with axial SpA and AS. It 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 is calculated for each item based on the measurement. The mean of the sum of the 5 scores provides the BASMI score. The higher the BASMI score the more severe the patient's limitation of movement due to their axial SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Measured: From Baseline to Week 24
Change From Baseline in the Spine Ankylosing Spondylitis Spine Magnetic Resonance Imaging (MRI) Scoring System for Disease Activity (ASspiMRI-a) in the Berlin Modification at Week 12
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. A VU is defined as the region between 2 virtual lines through the middle of each vertebra. Active inflammation is 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. Total spine ASspiMRI-a score in the Berlin modification can range from 0 to 69 with higher scores indicating higher disease activity. A negative value in total spine ASspiMRI-a score change from Baseline indicates an improvement from Baseline. The higher the negative value the higher the reduction of inflammation.
Measured: From Baseline to Week 12
Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Week 12
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. A negative value in SPARCC change from Baseline indicates an improvement from Baseline. The higher the negative value the higher the reduction of inflammation.
Measured: From Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionOct 2011
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for SpondyloarthropathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB BIOSCIENCES GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 UCB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01087762
- Sponsor's protocol ID
- AS001
- Other IDs
- 2009-011719-19, 2009
- Status last verified
- Nov 2016
- First submitted
- 15 Mar 2010
- Last updated
- 1 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Expanded access
- Available
Publications
Landewe R, Braun J, Deodhar A, Dougados M, Maksymowych WP, Mease PJ, Reveille JD, Rudwaleit M, van der Heijde D, Stach C, Hoepken B, Fichtner A, Coteur G, de Longueville M, Sieper J. Efficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis: 24-week results of a double-blind randomised placebo-controlled Phase 3 study. Ann Rheum Dis. 2014 Jan;73(1):39-47. doi: 10.1136/annrheumdis-2013-204231. Epub 2013 Sep 6.
PubMed 24013647Proft F, Vahldiek JL, Nicolaes J, Tham R, Hoepken B, Ufuktepe B, Poddubnyy D, Bressem KK. Machine learning vs human experts: sacroiliitis analysis from the RAPID-axSpA and C-OPTIMISE phase 3 axSpA trials. Rheumatol Adv Pract. 2025 Apr 18;9(2):rkae118. doi: 10.1093/rap/rkae118. eCollection 2025.
PubMed 40256636Rudwaleit M, Marzo-Ortega H, Navarro-Compan V, Tham R, Kumke T, Bauer L, de Peyrecave N, Kim M, Van den Bosch F. Exploratory analysis of the potential disconnect between objective inflammatory response and clinical response following certolizumab pegol treatment in patients with active axial spondyloarthritis. RMD Open. 2024 Aug 28;10(3):e004369. doi: 10.1136/rmdopen-2024-004369.
PubMed 39209369Baraliakos X, Kruse S, Auteri SE, de Peyrecave N, Nurminen T, Kumke T, Hoepken B, Braun J. Certolizumab pegol treatment in axial spondyloarthritis mitigates fat lesion development: 4-year post-hoc MRI results from a phase 3 study. Rheumatology (Oxford). 2022 Jul 6;61(7):2875-2885. doi: 10.1093/rheumatology/keab841.
PubMed 34791107Landewe R, Nurminen T, Davies O, Baeten D. A single determination of C-reactive protein does not suffice to declare a patient with a diagnosis of axial spondyloarthritis 'CRP-negative'. Arthritis Res Ther. 2018 Sep 14;20(1):209. doi: 10.1186/s13075-018-1707-8.
PubMed 30217232van der Heijde D, Braun J, Rudwaleit M, Purcaru O, Kavanaugh AF. Improvements in workplace and household productivity with certolizumab pegol treatment in axial spondyloarthritis: results to week 96 of a phase III study. RMD Open. 2018 Apr 9;4(1):e000659. doi: 10.1136/rmdopen-2018-000659. eCollection 2018.
PubMed 29670761van der Heijde D, Baraliakos X, Hermann KA, Landewe RBM, Machado PM, Maksymowych WP, Davies OR, de Peyrecave N, Hoepken B, Bauer L, Nurminen T, Braun J. Limited radiographic progression and sustained reductions in MRI inflammation in patients with axial spondyloarthritis: 4-year imaging outcomes from the RAPID-axSpA phase III randomised trial. Ann Rheum Dis. 2018 May;77(5):699-705. doi: 10.1136/annrheumdis-2017-212377. Epub 2018 Jan 17.
PubMed 29343510Braun J, Baraliakos X, Hermann KG, Landewe R, Machado PM, Maksymowych WP, Davies O, Hoepken B, Nurminen T, Stach C, van der Heijde D. Effect of certolizumab pegol over 96 weeks of treatment on inflammation of the spine and sacroiliac joints, as measured by MRI, and the association between clinical and MRI outcomes in patients with axial spondyloarthritis. RMD Open. 2017 Apr 24;3(1):e000430. doi: 10.1136/rmdopen-2017-000430. eCollection 2017.
PubMed 28848654van der Heijde D, Dougados M, Landewe R, Sieper J, Maksymowych WP, Rudwaleit M, Van den Bosch F, Braun J, Mease PJ, Kivitz AJ, Walsh J, Davies O, Bauer L, Hoepken B, Peterson L, Deodhar A. Sustained efficacy, safety and patient-reported outcomes of certolizumab pegol in axial spondyloarthritis: 4-year outcomes from RAPID-axSpA. Rheumatology (Oxford). 2017 Sep 1;56(9):1498-1509. doi: 10.1093/rheumatology/kex174.
PubMed 28498975van der Heijde D, Deodhar A, Fleischmann R, Mease PJ, Rudwaleit M, Nurminen T, Davies O. Early Disease Activity or Clinical Response as Predictors of Long-Term Outcomes With Certolizumab Pegol in Axial Spondyloarthritis or Psoriatic Arthritis. Arthritis Care Res (Hoboken). 2017 Jul;69(7):1030-1039. doi: 10.1002/acr.23092. Epub 2017 Jun 2.
PubMed 27696727Rudwaleit M, Rosenbaum JT, Landewe R, Marzo-Ortega H, Sieper J, van der Heijde D, Davies O, Bartz H, Hoepken B, Nurminen T, Deodhar A. Observed Incidence of Uveitis Following Certolizumab Pegol Treatment in Patients With Axial Spondyloarthritis. Arthritis Care Res (Hoboken). 2016 Jun;68(6):838-44. doi: 10.1002/acr.22848.
PubMed 26815944Sieper J, Kivitz A, van Tubergen A, Deodhar A, Coteur G, Woltering F, Landewe R. Impact of Certolizumab Pegol on Patient-Reported Outcomes in Patients With Axial Spondyloarthritis. Arthritis Care Res (Hoboken). 2015 Oct;67(10):1475-80. doi: 10.1002/acr.22594.
PubMed 25832312
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis
- ClinicalTrials.gov ID
- NCT01087762
- Acronym / sponsor ID
- AS001
- Conditions
- Spondyloarthropathies
- Keywords
- Certolizumab Pegol, Cimzia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- UCB BIOSCIENCES GmbHIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 16 Mar 2010 (estimated)
- Results
- Posted 25 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of two dose regimens of Certolizumab Pegol (CZP) in subjects with active axial Spondyloarthritis (axial SpA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| CZP 200 mg Q2W | Experimental | Biological: CZP 200 mg Q2W, Other: PlaceboSubjects received 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 onwards. At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. |
| CZP 400 mg Q4W | Experimental | Biological: CZP 400 mg Q4W, Other: PlaceboSubjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards. Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind. |
| Placebo | Placebo comparator | Other: PlaceboMatching Placebo to CZP injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16. After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg Q2W or CZP 400 mg Q4W. |
| Placebo to CZP 200 mg escape on Week 16 | Other | Biological: CZP 200 mg Q2W, Other: PlaceboMatching Placebo to CZP injections from Week 0 to Week 16. Subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16 and were treated with three loading doses of CZP 400 mg sc on Weeks 16, 18 and 20, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 22 onwards. Additionally, Placebo injections were administered as appropriate in order to maintain the study blind. |
| Placebo to CZP 400 mg escape on Week 16 | Other | Biological: CZP 400 mg Q4W, Other: PlaceboMatching Placebo to CZP injections from Week 0 to Week 16. Subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16 and were treated with three loading doses of CZP 400 mg sc on Weeks 16, 18 and 20, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 24 onwards. Additionally, Placebo injections were administered as appropriate in order to maintain the study blind. |
| Placebo to CZP 200 mg on Week 24 | Other | Biological: CZP 200 mg Q2W, Other: PlaceboMatching Placebo to CZP injections from Week 0 to Week 24. Three loading doses of CZP 400 mg sc were given on Weeks 24, 26 and 28, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 30 onwards. Additionally, Placebo injections were administered as appropriate in order to maintain the study blind. |
| Placebo to CZP 400 mg on Week 24 | Other | Biological: CZP 400 mg Q4W, Other: PlaceboMatching Placebo to CZP injections from Week 0 to Week 24. Three loading doses of CZP 400 mg sc were given on Weeks 24, 26 and 28, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 32 onwards. Additionally, Placebo injections were administered as appropriate in order to maintain the study blind. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Documented diagnosis of adult-onset axial Spondyloarthritis (SpA) of at least 3 months' duration as defined by the specified Assessment of Spondyloarthritis International Society (ASAS) criteria
- Active disease as defined by:
- Intolerance to or inadequate response to at least 1 Nonsteroidal Anti-Inflammatory Drug (NSAID)
Key exclusion criteria (12 listed)
- 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 to more than 2 previous biological agents for Axial Spondyloarthritis (SpA)
- History of or current chronic or recurrent infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CZP 200 mg Q2WAlso: Cimzia, CZP, Certolizumab Pegol200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W). | Biological | CZP 200 mg Q2W, Placebo to CZP 200 mg escape on Week 16, Placebo to CZP 200 mg on Week 24 |
| CZP 400 mg Q4WAlso: Cimzia, CZP, Certolizumab Pegol400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W). | Biological | CZP 400 mg Q4W, Placebo to CZP 400 mg escape on Week 16, Placebo to CZP 400 mg on Week 24 |
| PlaceboMatching Placebo to CZP injection. | Other | CZP 200 mg Q2W, CZP 400 mg Q4W, Placebo, Placebo to CZP 200 mg escape on Week 16, Placebo to CZP 200 mg on Week 24, Placebo to CZP 400 mg escape on Week 16, Placebo to CZP 400 mg on Week 24 |
Primary outcome
Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 12
Time frame: Week 12
The ASAS20 is 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 following domains: * Patient's Global Assessment of Disease Activity * Pain assessment (total spinal pain) * Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI)) * Inflammation (the mean of the 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 is defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit).
9 secondary outcomes
Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 24
Time frame: Week 24
Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 12
Time frame: From Baseline to Week 12
Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24
Time frame: From Baseline to Week 24
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12
Time frame: From Baseline to Week 12
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24
Time frame: From Baseline to Week 24
Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 12
Time frame: From Baseline to Week 12
Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 24
Time frame: From Baseline to Week 24
Change From Baseline in the Spine Ankylosing Spondylitis Spine Magnetic Resonance Imaging (MRI) Scoring System for Disease Activity (ASspiMRI-a) in the Berlin Modification at Week 12
Time frame: From Baseline to Week 12
Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Week 12
Time frame: From Baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24013647Landewe R, Braun J, Deodhar A, Dougados M, Maksymowych WP, Mease PJ, Reveille JD, Rudwaleit M, van der Heijde D, Stach C, Hoepken B, Fichtner A, Coteur G, de Longueville M, Sieper J. Efficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis: 24-week results of a double-blind randomised placebo-controlled Phase 3 study. Ann Rheum Dis. 2014 Jan;73(1):39-47. doi: 10.1136/annrheumdis-2013-204231. Epub 2013 Sep 6.
- Derived from this study: PubMed 40256636Proft F, Vahldiek JL, Nicolaes J, Tham R, Hoepken B, Ufuktepe B, Poddubnyy D, Bressem KK. Machine learning vs human experts: sacroiliitis analysis from the RAPID-axSpA and C-OPTIMISE phase 3 axSpA trials. Rheumatol Adv Pract. 2025 Apr 18;9(2):rkae118. doi: 10.1093/rap/rkae118. eCollection 2025.
- Derived from this study: PubMed 39209369Rudwaleit M, Marzo-Ortega H, Navarro-Compan V, Tham R, Kumke T, Bauer L, de Peyrecave N, Kim M, Van den Bosch F. Exploratory analysis of the potential disconnect between objective inflammatory response and clinical response following certolizumab pegol treatment in patients with active axial spondyloarthritis. RMD Open. 2024 Aug 28;10(3):e004369. doi: 10.1136/rmdopen-2024-004369.
- Derived from this study: PubMed 34791107Baraliakos X, Kruse S, Auteri SE, de Peyrecave N, Nurminen T, Kumke T, Hoepken B, Braun J. Certolizumab pegol treatment in axial spondyloarthritis mitigates fat lesion development: 4-year post-hoc MRI results from a phase 3 study. Rheumatology (Oxford). 2022 Jul 6;61(7):2875-2885. doi: 10.1093/rheumatology/keab841.
- Derived from this study: PubMed 30217232Landewe R, Nurminen T, Davies O, Baeten D. A single determination of C-reactive protein does not suffice to declare a patient with a diagnosis of axial spondyloarthritis 'CRP-negative'. Arthritis Res Ther. 2018 Sep 14;20(1):209. doi: 10.1186/s13075-018-1707-8.
- Derived from this study: PubMed 29670761van der Heijde D, Braun J, Rudwaleit M, Purcaru O, Kavanaugh AF. Improvements in workplace and household productivity with certolizumab pegol treatment in axial spondyloarthritis: results to week 96 of a phase III study. RMD Open. 2018 Apr 9;4(1):e000659. doi: 10.1136/rmdopen-2018-000659. eCollection 2018.
- Derived from this study: PubMed 29343510van der Heijde D, Baraliakos X, Hermann KA, Landewe RBM, Machado PM, Maksymowych WP, Davies OR, de Peyrecave N, Hoepken B, Bauer L, Nurminen T, Braun J. Limited radiographic progression and sustained reductions in MRI inflammation in patients with axial spondyloarthritis: 4-year imaging outcomes from the RAPID-axSpA phase III randomised trial. Ann Rheum Dis. 2018 May;77(5):699-705. doi: 10.1136/annrheumdis-2017-212377. Epub 2018 Jan 17.
- Derived from this study: PubMed 28848654Braun J, Baraliakos X, Hermann KG, Landewe R, Machado PM, Maksymowych WP, Davies O, Hoepken B, Nurminen T, Stach C, van der Heijde D. Effect of certolizumab pegol over 96 weeks of treatment on inflammation of the spine and sacroiliac joints, as measured by MRI, and the association between clinical and MRI outcomes in patients with axial spondyloarthritis. RMD Open. 2017 Apr 24;3(1):e000430. doi: 10.1136/rmdopen-2017-000430. eCollection 2017.
- Derived from this study: PubMed 28498975van der Heijde D, Dougados M, Landewe R, Sieper J, Maksymowych WP, Rudwaleit M, Van den Bosch F, Braun J, Mease PJ, Kivitz AJ, Walsh J, Davies O, Bauer L, Hoepken B, Peterson L, Deodhar A. Sustained efficacy, safety and patient-reported outcomes of certolizumab pegol in axial spondyloarthritis: 4-year outcomes from RAPID-axSpA. Rheumatology (Oxford). 2017 Sep 1;56(9):1498-1509. doi: 10.1093/rheumatology/kex174.
- Derived from this study: PubMed 27696727van der Heijde D, Deodhar A, Fleischmann R, Mease PJ, Rudwaleit M, Nurminen T, Davies O. Early Disease Activity or Clinical Response as Predictors of Long-Term Outcomes With Certolizumab Pegol in Axial Spondyloarthritis or Psoriatic Arthritis. Arthritis Care Res (Hoboken). 2017 Jul;69(7):1030-1039. doi: 10.1002/acr.23092. Epub 2017 Jun 2.
- Derived from this study: PubMed 26815944Rudwaleit M, Rosenbaum JT, Landewe R, Marzo-Ortega H, Sieper J, van der Heijde D, Davies O, Bartz H, Hoepken B, Nurminen T, Deodhar A. Observed Incidence of Uveitis Following Certolizumab Pegol Treatment in Patients With Axial Spondyloarthritis. Arthritis Care Res (Hoboken). 2016 Jun;68(6):838-44. doi: 10.1002/acr.22848.
- Derived from this study: PubMed 25832312Sieper J, Kivitz A, van Tubergen A, Deodhar A, Coteur G, Woltering F, Landewe R. Impact of Certolizumab Pegol on Patient-Reported Outcomes in Patients With Axial Spondyloarthritis. Arthritis Care Res (Hoboken). 2015 Oct;67(10):1475-80. doi: 10.1002/acr.22594.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Clinical Trial Call Center study director
+1 877 822 9493 UCB
104 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CZP 200 mg Q2W and CZP 400 mg Q4W in people with Spondyloarthropathies, run by UCB BIOSCIENCES GmbH at 104 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 104 sites in United States, Poland, Argentina, Germany, Czechia and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01087762, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2018.