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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011719-19 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CZP 200 mg Q2W | Biological | 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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). | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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). |
Not provided
Inclusion Criteria:
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)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 UCB | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 961 | Birmingham | Alabama | United States | |||
| 953 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24013647 | Result | 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. | |
| 40256636 |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
Not provided
Patients with positive Tuberculosis (TB) tests within Screening Period, but no signs and symptoms of active TB had to be treated with prophylactic TB treatment for at least 4 weeks prior to first study drug administration.
This is a multicenter study with 128 sites in North America, Latin America, Western Europe, and Central/Eastern Europe. 325 subjects are included in Randomized Set (RS) shown in Participant Flow for the interim period, and 315 for the final analysis (10 subjects dropped out before receiving a CZP dose), which is an Intention-to-Treat (ITT) dataset.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching Placebo to Certolizumab Pegol (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 every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W). Placebo : Matching Placebo to CZP injection. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double Blind Period (Weeks 0-24) |
|
Not provided
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Not provided
|
| 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. |
|
| 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. |
|
| 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. |
|
|
| CZP 400 mg Q4W | Biological | 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W). |
|
|
| Placebo | Other | Matching Placebo to CZP injection. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | From Baseline to Week 12 |
| Tuscaloosa |
| Alabama |
| United States |
| 954 | Peoria | Arizona | United States |
| 971 | Scottsdale | Arizona | United States |
| 987 | Tucson | Arizona | United States |
| 974 | La Jolla | California | United States |
| 973 | Los Angeles | California | United States |
| 966 | Palm Desert | California | United States |
| 952 | San Diego | California | United States |
| 957 | Aventura | Florida | United States |
| 962 | Fort Lauderdale | Florida | United States |
| 959 | Orange Park | Florida | United States |
| 990 | Pinellas Park | Florida | United States |
| 958 | Vero Beach | Florida | United States |
| 964 | Hagerstown | Maryland | United States |
| 969 | Eagan | Minnesota | United States |
| 984 | Flowood | Mississippi | United States |
| 965 | Florissant | Missouri | United States |
| 950 | St Louis | Missouri | United States |
| 985 | Brooklyn | New York | United States |
| 963 | Asheville | North Carolina | United States |
| 977 | Cleveland | Ohio | United States |
| 951 | Middleburg Heights | Ohio | United States |
| 970 | Oklahoma City | Oklahoma | United States |
| 982 | Portland | Oregon | United States |
| 972 | Duncansville | Pennsylvania | United States |
| 975 | Dallas | Texas | United States |
| 978 | Houston | Texas | United States |
| 983 | Houston | Texas | United States |
| 967 | San Antonio | Texas | United States |
| 981 | Salt Lake City | Utah | United States |
| 968 | Seattle | Washington | United States |
| 700 | Buenos Aires | Argentina |
| 701 | Buenos Aires | Argentina |
| 704 | Buenos Aires | Argentina |
| 705 | Córdoba | Argentina |
| 709 | La Plata | Argentina |
| 706 | Rosario | Argentina |
| 710 | San Juan | Argentina |
| 702 | San Miguel de Tucumán | Argentina |
| 708 | San Miguel de Tucumán | Argentina |
| 153 | Brussels | Belgium |
| 152 | Ghent | Belgium |
| 151 | Liège | Belgium |
| 760 | Campinas | Brazil |
| 750 | Curitiba | Brazil |
| 761 | Goiânia | Brazil |
| 756 | São Paulo | Brazil |
| 907 | Victoria | British Columbia | Canada |
| 903 | Winnipeg | Manitoba | Canada |
| 900 | St. John's | Newfoundland and Labrador | Canada |
| 910 | Windsor | Ontario | Canada |
| 902 | Sainte-Foy | Quebec | Canada |
| 504 | Brno | Czechia |
| 501 | Hlučín | Czechia |
| 500 | Pardubice | Czechia |
| 502 | Prague | Czechia |
| 505 | Terezín | Czechia |
| 503 | Zlín | Czechia |
| 200 | Boulogne-Billan Court | France |
| 201 | Lille | France |
| 205 | Limoges | France |
| 206 | Montpellier | France |
| 204 | Paris | France |
| 202 | Tours | France |
| 257 | Berlin | Germany |
| 258 | Berlin | Germany |
| 255 | Freiburg im Breisgau | Germany |
| 254 | Hamburg | Germany |
| 250 | Herne | Germany |
| 253 | Leipzig | Germany |
| 260 | München | Germany |
| 263 | München | Germany |
| 256 | Ratingen | Germany |
| 303 | Budapest | Hungary |
| 305 | Budapest | Hungary |
| 302 | Debrecen | Hungary |
| 306 | Miskolc | Hungary |
| 300 | Veszprém | Hungary |
| 352 | Ancona | Italy |
| 351 | Florence | Italy |
| 350 | Pisa | Italy |
| 802 | Cuernavaca | Mexico |
| 801 | Monterrey | Mexico |
| 401 | Maastricht | Netherlands |
| 400 | Rotterdam | Netherlands |
| 458 | Bialystok | Poland |
| 452 | Dąbrówka | Poland |
| 455 | Elblag | Poland |
| 459 | Gdanks | Poland |
| 457 | Krakow | Poland |
| 450 | Lublin | Poland |
| 454 | Poznan | Poland |
| 453 | Torun | Poland |
| 456 | Warsaw | Poland |
| 462 | Warsaw | Poland |
| 550 | Mérida | Spain |
| 554 | Santander | Spain |
| 552 | Santiago de Compostela | Spain |
| 553 | Seville | Spain |
| 605 | Barnsley | United Kingdom |
| 600 | Leeds | United Kingdom |
| 602 | London | United Kingdom |
| 601 | Salford | United Kingdom |
| Derived |
| Proft 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. |
| 39209369 | Derived | Rudwaleit 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. |
| 34791107 | Derived | Baraliakos 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. |
| 30217232 | Derived | Landewe 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. |
| 29670761 | Derived | van 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. |
| 29343510 | Derived | van 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. |
| 28848654 | Derived | Braun 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. |
| 28498975 | Derived | van 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. |
| 27696727 | Derived | van 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. |
| 26815944 | Derived | Rudwaleit 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. |
| 25832312 | Derived | Sieper 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. |
| FG001 | CZP 200 mg Q2W | 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. Placebo : Matching Placebo to CZP injection. CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W). |
| FG002 | CZP 400 mg Q4W | 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. Placebo : Matching Placebo to CZP injection. CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W). |
| FG003 | All CZP 200 mg | All subjects who received CZP at the specified dose (200 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24. Placebo : Matching Placebo to CZP injection. CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W). |
| FG004 | All CZP 400 mg | All subjects who received CZP at the specified dose (400 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24. Placebo : Matching Placebo to CZP injection. CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W). |
| COMPLETED |
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| NOT COMPLETED |
|
|
| Open-Label Period (Weeks 48-204) |
|
|
Baseline Characteristics refer to the Randomized Set (RS), which is an Intention-to-Treat (ITT) dataset.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matching Placebo to Certolizumab Pegol (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 every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W). Placebo : Matching Placebo to CZP injection. |
| BG001 | CZP 200 mg Q2W | 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. Placebo : Matching Placebo to CZP injection. CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W). |
| BG002 | CZP 400 mg Q4W | 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. Placebo : Matching Placebo to CZP injection. CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W). |
| BG003 | Total Title |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | kilogram (kg) |
| |||||||||||||||
| Height | Mean | Standard Deviation | centimeter (cm) |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
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). | Intention-to-treat dataset was the Randomized Set (RS). RS with non-responder imputation: subjects who withdrew for any reason or placebo subjects who used escape medication are considered as non-responders from drop out timepoint or when escape therapy was initiated. Subjects with missing data at a visit are non-responders for that visit, too. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 12 |
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| Secondary | 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:
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). | Intention-to-treat dataset was the Randomized Set (RS). RS with non-responder imputation: subjects who withdrew for any reason or placebo subjects who used escape medication are considered as non-responders from drop out timepoint or when escape therapy was initiated. Subjects with missing data at a visit are non-responders for that visit, too. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 24 |
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| Secondary | 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. | Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 12 measurements, last observation prior to the early withdrawal or Week 12 is carried forward to Week 12. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | From Baseline to Week 12 |
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| Secondary | 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. | Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 24 measurements, or placebo subjects who used escape medication, last observation prior to early withdrawal or Week 24 or before receiving CZP is carried forward to Week 24. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | From Baseline to Week 24 |
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| Secondary | 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. | Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 12 measurements, last observation prior to the early withdrawal or Week 12 is carried forward to Week 12. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | From Baseline to Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 24 measurements, or placebo subjects who used escape medication, last observation prior to early withdrawal or Week 24 or before receiving CZP is carried forward to Week 24. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | From Baseline to Week 24 |
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| Secondary | 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. | Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 12 measurements, last observation prior to the early withdrawal or Week 12 is carried forward to Week 12. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | From Baseline to Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 24 measurements, or placebo subjects who used escape medication, last observation prior to early withdrawal or Week 24 or before receiving CZP is carried forward to Week 24. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | From Baseline to Week 24 |
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| Secondary | 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. | The analysis was performed in the Magnetic Resonance Imaging (MRI) Set, a subgroup of subjects participating in an imaging substudy, where MRI measurements at Baseline and Week 12 were performed. Of the 325 patients randomized, 153 participated in the imaging substudy. Of these 153 subjects in the MRI Set, 148 are included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | From Baseline to Week 12 |
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| Secondary | 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. | The analysis was performed in the Magnetic Resonance Imaging (MRI) Set, a subgroup of subjects participating in an imaging substudy, where MRI measurements at Baseline and Week 12 were performed. Of the 325 patients randomized, 153 participated in the imaging substudy. Of these 153 subjects in the MRI Set, 140 are included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | From Baseline to Week 12 |
|
Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All CZP 200 mg (Safety Analysis) | All subjects who received CZP at the specified dose (200 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24. Placebo : Matching Placebo to CZP injection. CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W). | 35 | 158 | 142 | 158 | ||
| EG001 | All CZP 400 mg (Safety Analysis) | All subjects who received CZP at the specified dose (400 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24. Placebo : Matching Placebo to CZP injection. CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W). | 34 | 157 | 127 | 157 | ||
| EG002 | All CZP 200 mg + 400 mg | This arm shows all patients treated with Certolizumab Pegol (CZP) at least once. Hence, this arm is a combination of arm All CZP 200 mg and arm All CZP 400 mg. | 69 | 315 | 269 | 315 | ||
| EG003 | Placebo | Matching Placebo to Certolizumab Pegol (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 every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W). Placebo : Matching Placebo to CZP injection. | 5 | 107 | 28 | 107 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hilar lymphadenopathy | Blood and lymphatic system disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Paratracheal lymphadenopathy | Blood and lymphatic system disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Retinal vein occlusion | Eye disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Sigmoiditis | Gastrointestinal disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Cholelithiasis migration | Hepatobiliary disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA14.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA14.1 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA14.1 | Non-systematic Assessment |
| |
| Mycobacterial infection | Infections and infestations | MedDRA14.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA14.1 | Non-systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA14.1 | Non-systematic Assessment |
| |
| Haemophilus infection | Infections and infestations | MedDRA14.1 | Non-systematic Assessment |
| |
| Herpes zoster disseminated | Infections and infestations | MedDRA14.1 | Non-systematic Assessment |
| |
| Pneumonia legionella | Infections and infestations | MedDRA14.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA14.1 | Non-systematic Assessment |
| |
| Infected dermal cyst | Infections and infestations | MedDRA14.1 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA14.1 | Non-systematic Assessment |
| |
| Latent tuberculosis | Infections and infestations | MedDRA14.1 | Non-systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA14.1 | Non-systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA14.1 | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA14.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA14.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA14.1 | Non-systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA14.1 | Non-systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA14.1 | Non-systematic Assessment |
| |
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA14.1 | Non-systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA14.1 | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA14.1 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA14.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA14.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Ankylosing spondylitis | Musculoskeletal and connective tissue disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Spondylitis | Musculoskeletal and connective tissue disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Cholesterol granuloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA14.1 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA14.1 | Non-systematic Assessment |
| |
| Squamous cell carcinoma of the | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA14.1 | Non-systematic Assessment |
| |
| Astrocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA14.1 | Non-systematic Assessment |
| |
| Morton's neuroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA14.1 | Non-systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA14.1 | Non-systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Cerebrovascular insufficiency | Nervous system disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA14.1 | Non-systematic Assessment |
| |
| Pregnancy on contraceptive | Pregnancy, puerperium and perinatal conditions | MedDRA14.1 | Non-systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Conversion disorder | Psychiatric disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary | Respiratory, thoracic and mediastinal disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Diffuse alveolar damage | Respiratory, thoracic and mediastinal disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Bone graft | Surgical and medical procedures | MedDRA14.1 | Non-systematic Assessment |
| |
| Abortion induced | Surgical and medical procedures | MedDRA14.1 | Non-systematic Assessment |
| |
| Inflammatory bowel disease | Gastrointestinal disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA14.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Uveitis | Eye disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA14.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA14.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA14.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA14.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA14.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA14.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA14.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA14.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA14.1 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA14.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA14.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA14.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA14.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA14.1 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA14.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA14.1 | Non-systematic Assessment |
| |
| Tuberculin test positive | Investigations | MedDRA14.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA14.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Spondylitis | Musculoskeletal and connective tissue disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Ankylosing spondylitis | Musculoskeletal and connective tissue disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA14.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA14.1 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | +1887822 | 9493 |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| ID | Term |
|---|---|
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068582 | Certolizumab Pegol |
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D007140 | Immunoglobulin Fab Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Protocol Violation |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Other |
|
| SAE, non-fatal |
|
| AE, non-serious non-fatal |
|
| SAE, non-fatal + AE, non-serious/fatal |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Superiority or Other |
| A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected. | Wald-test, 2-sided | Wald test and Confidence Interval (CI) calculation were performed without continuity correction. | <0.001 | Difference of Certolizumab Pegol 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level. | Mean Difference (Final Values) | 25.2 | 2-Sided | 95 | 12.3 | 38.2 | Superiority or Other |
| OG001 | CZP 200 mg Q2W (FAS) | 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. Placebo : Matching Placebo to CZP injection. CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W). |
| OG002 | CZP 400 mg Q4W (FAS) | 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. Placebo : Matching Placebo to CZP injection. CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W). |
| OG003 | CZP 200 mg Q2W and CZP 400 mg Q4W (FAS) | This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. 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)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards. Subjects in both CZP arms received additional placebo injections to maintain the study blind. Placebo : Matching Placebo to CZP injection. CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W). CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W). |
|
|
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| OG002 | CZP 400 mg Q4W (FAS) | 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. Placebo : Matching Placebo to CZP injection. CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W). |
| OG003 | CZP 200 mg Q2W and CZP 400 mg Q4W (FAS) | This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. 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)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards. Subjects in both CZP arms received additional placebo injections to maintain the study blind. Placebo : Matching Placebo to CZP injection. CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W). CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W). |
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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.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
| OG002 | CZP 400 mg Q4W (FAS) | 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. Placebo : Matching Placebo to CZP injection. CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W). |
| OG003 | CZP 200 mg Q2W and CZP 400 mg Q4W (FAS) | This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. 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)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards. Subjects in both CZP arms received additional placebo injections to maintain the study blind. Placebo : Matching Placebo to CZP injection. CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W). CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W). |
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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.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
| OG002 | CZP 400 mg Q4W (FAS) | 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. Placebo : Matching Placebo to CZP injection. CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W). |
| OG003 | CZP 200 mg Q2W and CZP 400 mg Q4W (FAS) | This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. 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)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards. Subjects in both CZP arms received additional placebo injections to maintain the study blind. Placebo : Matching Placebo to CZP injection. CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W). CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W). |
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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. Placebo : Matching Placebo to CZP injection. CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W). |
| OG002 | CZP 400 mg Q4W (FAS) | 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. Placebo : Matching Placebo to CZP injection. CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W). |
| OG003 | CZP 200 mg Q2W and CZP 400 mg Q4W (FAS) | This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. 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)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards. Subjects in both CZP arms received additional placebo injections to maintain the study blind. Placebo : Matching Placebo to CZP injection. CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W). CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W). |
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| OG001 | CZP 200 mg Q2W (FAS) | 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. Placebo : Matching Placebo to CZP injection. CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W). |
| OG002 | CZP 400 mg Q4W (FAS) | 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. Placebo : Matching Placebo to CZP injection. CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W). |
| OG003 | CZP 200 mg Q2W and CZP 400 mg Q4W (FAS) | This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. 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)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards. Subjects in both CZP arms received additional placebo injections to maintain the study blind. Placebo : Matching Placebo to CZP injection. CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W). CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W). |
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| OG001 | CZP 200 mg Q2W (FAS) | 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. Placebo : Matching Placebo to CZP injection. CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W). |
| OG002 | CZP 400 mg Q4W (FAS) | 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. Placebo : Matching Placebo to CZP injection. CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W). |
| OG003 | CZP 200 mg Q2W and CZP 400 mg Q4W (FAS) | This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. 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)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards. Subjects in both CZP arms received additional placebo injections to maintain the study blind. Placebo : Matching Placebo to CZP injection. CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W). CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W). |
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| OG001 | CZP 200 mg Q2W (FAS) | 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. Placebo : Matching Placebo to CZP injection. CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W). |
| OG002 | CZP 400 mg Q4W (FAS) | 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. Placebo : Matching Placebo to CZP injection. CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W). |
| OG003 | CZP 200 mg Q2W and CZP 400 mg Q4W (FAS) | This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. 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)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards. Subjects in both CZP arms received additional placebo injections to maintain the study blind. Placebo : Matching Placebo to CZP injection. CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W). CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W). |
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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.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
| OG002 | CZP 400 mg Q4W (FAS) | 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. Placebo : Matching Placebo to CZP injection. CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W). |
| OG003 | CZP 200 mg Q2W and CZP 400 mg Q4W (FAS) | This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. 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)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards. Subjects in both CZP arms received additional placebo injections to maintain the study blind. Placebo : Matching Placebo to CZP injection. CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W). CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W). |
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