Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003492-36 | EudraCT Number |
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The purpose of this study is to investigate the efficacy and safety of two dose levels of certolizumab pegol compared to active comparator and placebo in adults with moderate to severe chronic plaque psoriasis.
This study consists of the following Periods:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CZP 200 mg | Experimental | Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg every two weeks (Q2W) from Week 6 to Week 14. The treatment received from Week 16 to Week 48 is based on initial treatment and response to treatment at Week 16:
Subjects can enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. |
|
| CZP 400 mg | Experimental | Certolizumab Pegol subcutaneous (sc) injection 400 mg every two weeks (Q2W) through Week 14. The treatment received from Week 16 to Week 48 is based on initial treatment and response to treatment at Week 16:
Subjects can enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. |
|
| Etanercept | Active Comparator | Etanercept (ETN) subcutaneous (sc) injection 50 mg twice weekly through Week 12. The treatment received from Week 16 to Week 48 is based on initial treatment and response to treatment at Week 16:
Subjects can enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Certolizumab Pegol | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 12 | The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear Response (With at Least 2 Category Improvement) at Week 12 | The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe. | Week 12 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | +1 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ps0003 317 | Mobile | Alabama | 36608 | United States | ||
| Ps0003 306 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29660425 | Result | Lebwohl M, Blauvelt A, Paul C, Sofen H, Weglowska J, Piguet V, Burge D, Rolleri R, Drew J, Peterson L, Augustin M. Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks of a phase 3, multicenter, randomized, double-blind, etanercept- and placebo-controlled study (CIMPACT). J Am Acad Dermatol. 2018 Aug;79(2):266-276.e5. doi: 10.1016/j.jaad.2018.04.013. Epub 2018 Apr 14. | |
| 34192387 |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
The study included a Screening Period, an Initial Treatment Period up to Week 16, a Maintenance Treatment Period up to Week 48, an Open-Label Extension Treatment Period up to Week 144 and a Safety Follow-up Period up to Week 157. The Participants Flow refers to the Randomized Set, the Maintenance Set and the Open Label Set.
This study started to enroll participants in February 2015, from multiple sites in Europe and United States and concluded in December 2018. 559 participants are included in the Randomized Set (RS) shown in the Participant Flow.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Q2W | Placebo subcutaneous (sc) injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 continued to receive blinded Placebo. PASI75 non-responders at Week 16 were removed from blinded study medication and escaped to Certolizumab pegol (CZP) 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period (Weeks 16-48) and receive CZP under certain conditions. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Initial Period (Baseline to Week 16) |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Placebo Comparator | Placebo subcutaneous (sc) injection every two weeks (Q2W). The treatment received from Week 16 to Week 48 is based on initial treatment and response to treatment at Week 16:
Subjects can enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. |
|
|
| Etanercept | Biological |
|
|
|
| Placebo | Other |
|
|
|
| Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 12 |
The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. |
| Week 12 |
| Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16 | The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. | Week 16 |
| Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear Response (With at Least 2 Category Improvement) at Week 16 | The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe. | Week 16 |
| Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 16 | The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. | Week 16 |
| Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 48 for Those Achieving PASI75 at Week 16 | The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. | Week 48 |
| Little Rock |
| Arkansas |
| 72204 |
| United States |
| Ps0003 301 | Beverly Hills | California | 90212 | United States |
| Ps0003 307 | Los Angeles | California | 90045 | United States |
| Ps0003 405 | San Diego | California | 92123 | United States |
| Ps0003 316 | Washington D.C. | District of Columbia | 20037 | United States |
| Ps0003 304 | West Palm Beach | Florida | 33409 | United States |
| Ps0003 302 | Springfield | Illinois | 62703 | United States |
| Ps0003 313 | West Dundee | Illinois | 60118 | United States |
| Ps0003 310 | Indianapolis | Indiana | 46256 | United States |
| Ps0003 400 | Henderson | Nevada | 89052 | United States |
| Ps0003 319 | Verona | New Jersey | 07044-29 | United States |
| Ps0003 404 | Buffalo | New York | 14203 | United States |
| Ps0003 407 | Portland | Oregon | 97223 | United States |
| Ps0003 309 | Johnston | Rhode Island | 02919 | United States |
| Ps0003 401 | Dallas | Texas | 75246 | United States |
| Ps0003 403 | Houston | Texas | 77065 | United States |
| Ps0003 406 | San Antonio | Texas | 78213 | United States |
| Ps0003 311 | Webster | Texas | 77598 | United States |
| Ps0003 345 | Dupnitsa | Kyustendil | Bulgaria |
| Ps0003 343 | Sofia | Sofia-Grad | Bulgaria |
| Ps0003 344 | Plovdiv | Bulgaria |
| Ps0003 342 | Varna | Bulgaria |
| Ps0003 353 | Pardubice | District of Columbia | Czechia |
| Ps0003 351 | Pardubice | Czechia |
| Ps0003 352 | Prague | Czechia |
| Ps0003 350 | Ústà nad Labem | Czechia |
| Ps0003 320 | Nice | France |
| Ps0003 325 | Toulouse | France |
| Ps0003 374 | Friedrichshafen | Baden-Wurttemberg | Germany |
| Ps0003 373 | Munich | Bavaria | Germany |
| Ps0003 368 | Frankfurt am Main | Hesse | Germany |
| Ps0003 378 | Bochum | North Rhine-Westphalia | Germany |
| Ps0003 371 | Wuppertal | North Rhine-Westphalia | Germany |
| Ps0003 370 | Mainz | Rhineland-Palatinate | Germany |
| Ps0003 365 | Kiel | Schleswig-Holstein | Germany |
| Ps0003 363 | Erfurt | Thuringia | Germany |
| Ps0003 367 | Berlin | Germany |
| Ps0003 372 | Berlin | Germany |
| Ps0003 375 | Berlin | Germany |
| Ps0003 369 | Dresden | Germany |
| Ps0003 361 | Giessen | Germany |
| Ps0003 362 | Hamburg | Germany |
| Ps0003 366 | Hanover | Germany |
| Ps0003 381 | Orosháza | Bekes County | Hungary |
| Ps0003 380 | Debrecen | Hajdú-Bihar | Hungary |
| Ps0003 382 | Budapest | Hungary |
| Ps0003 383 | Budapest | Hungary |
| Ps0003 384 | Budapest | Hungary |
| Ps0003 340 | Breda | Netherlands |
| Ps0003 424 | Poznan | Greater Poland Voivodeship | Poland |
| Ps0003 330 | Torun | Kuyavian-Pomeranian Voivodeship | Poland |
| Ps0003 422 | Wroclaw | Lower Silesian Voivodeship | Poland |
| Ps0003 335 | Lublin | Lublin Voivodeship | Poland |
| Ps0003 338 | Warsaw | Masovian Voivodeship | Poland |
| Ps0003 421 | Warsaw | Masovian Voivodeship | Poland |
| Ps0003 333 | Bialystok | Podlaskie Voivodeship | Poland |
| Ps0003 334 | Katowice | Silesian Voivodeship | Poland |
| Ps0003 425 | Bialystok | Poland |
| Ps0003 427 | Gdansk | Poland |
| Ps0003 423 | Gdynia | Poland |
| Ps0003 332 | Szczecin | Poland |
| Ps0003 336 | Warsaw | Poland |
| Ps0003 339 | Wroclaw | Poland |
| Ps0003 390 | Dundee | Angus | United Kingdom |
| Ps0003 391 | Hexham | Northumberland | United Kingdom |
| Ps0003 395 | Cardiff | Wales | United Kingdom |
| Ps0003 393 | Edgbaston | United Kingdom |
| Ps0003 394 | Liverpool | United Kingdom |
| Ps0003 392 | Manchester | United Kingdom |
| Result |
| Warren RB, Lebwohl M, Sofen H, Piguet V, Augustin M, Brock F, C Arendt, Fierens F, Blauvelt A. Three-year efficacy and safety of certolizumab pegol for the treatment of plaque psoriasis: results from the randomized phase 3 CIMPACT trial. J Eur Acad Dermatol Venereol. 2021 Dec;35(12):2398-2408. doi: 10.1111/jdv.17486. Epub 2021 Aug 17. |
| 32531798 | Derived | Blauvelt A, Paul C, van de Kerkhof P, Warren RB, Gottlieb AB, Langley RG, Brock F, Arendt C, Boehnlein M, Lebwohl M, Reich K. Long-term safety of certolizumab pegol in plaque psoriasis: pooled analysis over 3 years from three phase III, randomized, placebo-controlled studies. Br J Dermatol. 2021 Apr;184(4):640-651. doi: 10.1111/bjd.19314. Epub 2020 Sep 6. |
| FG001 | Etanercept | Etanercept (ETN) 50 mg subcutaneous (sc) injections twice per week throughout Week 11.5. •PASI75 responders at Week 16 were re-randomized to either CZP (loading dose of 400 mg at Weeks 16, 18, and 20 followed by 200 mg Q2W) or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. |
| FG002 | CZP 200 mg Q2W | CZP 400 mg injections at Weeks 0, 2, 4, followed by CZP 200 mg every 2 weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W); with Placebo administered on alternate dosing weeks to maintain the blind) Or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. |
| FG003 | CZP 400 mg Q2W | CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. |
| FG004 | Placebo/Placebo Q2W | This arm consisted of participants initially randomized in the Placebo arm, who achieved a PASI75 response at Week 16 and continued to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). |
| FG005 | Etanercept/Placebo Q2W | This arm consisted of participants initially randomized in the Etanercept arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). |
| FG006 | Etanercept/CZP 200 mg Q2W | This arm consisted of participants initially randomized in the Etanercept arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). |
| FG007 | CZP 200 mg Q2W/Placebo Q2W | This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). |
| FG008 | CZP 200 mg Q2W/CZP 200 mg Q2W | This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). |
| FG009 | CZP 200 mg Q2W/CZP 400 mg Q4W | This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q4W in the Maintenance Period (Week 16 to Week 48). |
| FG010 | CZP 400 mg Q2W/Placebo Q2W | This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). |
| FG011 | CZP 400 mg Q2W/CZP 200 mg Q2W | This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). |
| FG012 | CZP 400 mg Q2W/CZP 400 mg Q2W | This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q2W in the Maintenance Period (Week 16 to Week 48). |
| FG013 | Placebo Q2W/Escape CZP 400 mg Q2W | This arm consisted of participants initially randomized in the Placebo arm, who did not achieve a PASI75 response at Week 16 escaped from the blinded treatment and received CZP 400 mg every two weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study. |
| FG014 | Etanercept/Escape CZP 400 mg Q2W | This arm consisted of participants initially randomized in the Etanercept arm, who did not achieve a PASI75 response at Week 16 escaped from the treatment and received CZP 400 mg every two weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study. |
| FG015 | CZP 200 mg Q2W/Escape CZP 400 mg Q2W | This arm consisted of participants initially randomized in the CZP 200 mg arm, who did not achieve a PASI75 response at Week 16 escaped from the blinded treatment and received CZP 400 mg every two weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study. |
| FG016 | CZP 400 mg Q2W/Escape CZP 400 mg Q2W | This arm consisted of participants initially randomized in the CZP 400 mg arm, who did not achieve a PASI75 response at Week 16 escaped from the blinded treatment and received CZP 400 mg every two weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study. |
| FG017 | Placebo/CZP 200 mg Q2W OLE | This arm consisted of participants from the Placebo-controlled Maintenance Period, who achieved PASI50 response (had no relapse) at Week 48 and entered the 96-Weeks OLE Period receiving CZP 200 mg Q2W. |
| FG018 | CZP 200 mg Q2W/CZP 200 mg Q2W OLE | This arm consisted of participants who received CZP 200 mg Q2W in the Maintenance Period, who achieved a PASI50 response (had no relapse) at Week 48 and entered OLE. |
| FG019 | CZP 400 mg Q4W/CZP 200 mg Q2W OLE | This arm consisted of participants who received CZP 400 mg Q4W in the Maintenance Period, who achieved a PASI50 response (had no relapse) at Week 48 and entered OLE on the CZP 200mg Q2W dose. |
| FG020 | CZP 400 mg Q2W/CZP 200 mg Q2W OLE | This arm consisted of participants who received CZP 400 mg Q2W in the Maintenance Period, who achieved a PASI50 response (had no relapse) at Week 48 and entered OLE on the CZP 200mg Q2W dose. |
| FG021 | Esc CZP 400 mg Q2W/CZP 400 mg Q2W OLE | This arm consisted of participants who received open-label CZP 400mg Q2W in the Maintenance Period and entered OLE. |
| FG022 | Placebo/CZP 400 mg Q2W OLE | This arm consisted of participants from the Placebo-controlled Maintenance Period, who did not achieve PASI50 response (had relapse) and entered the 96-weeks OLE Period receiving CZP 400 mg Q2W. |
| FG023 | Any CZP/CZP 400 mg Q2W OLE | This arm consisted of participants who relapsed on CZP 200 mg Q2W, CZP 400 mg Q4W and 400 mg Q2W. |
| Completed Week 16 |
|
| Finished Wk16 Started Maintenance Period |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Maintenance Period (Week 16 to Week 48) |
|
|
| Open-Label Period (Week 48 to Week 144) |
|
|
Baseline Characteristics refer to the Randomized Set consisting of all participants randomized into the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Q2W | Placebo subcutaneous (sc) injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 continued to receive blinded Placebo. PASI75 non-responders at Week 16 were removed from blinded study medication and escaped to Certolizumab pegol (CZP) 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period (Weeks 16-48) and receive CZP under certain conditions. |
| BG001 | Etanercept | Etanercept (ETN) 50 mg subcutaneous (sc) injections twice per week throughout Week 11.5. •PASI75 responders at Week 16 were re-randomized to either CZP (loading dose of 400 mg at Weeks 16, 18, and 20 followed by 200 mg Q2W) or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. |
| BG002 | CZP 200 mg Q2W | CZP 400 mg injections at Weeks 0, 2, 4, followed by CZP 200 mg every 2 weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W); with Placebo administered on alternate dosing weeks to maintain the blind) Or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. |
| BG003 | CZP 400 mg Q2W | CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. |
| BG004 | Total Title |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 12 | The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. | The Randomized Set (RS) consisted of all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation. | Posted | Number | percentage of participants | Week 12 |
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| Secondary | Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear Response (With at Least 2 Category Improvement) at Week 12 | The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe. | The Randomized Set (RS) consisted of all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation. | Posted | Number | percentage of participants | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 12 | The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. | The Randomized Set (RS) consisted of all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation. | Posted | Number | percentage of participants | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16 | The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. | The Randomized Set (RS) consisted of all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation. | Posted | Number | percentage of participants | Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear Response (With at Least 2 Category Improvement) at Week 16 | The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe. | The Randomized Set (RS) consisted of all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation. | Posted | Number | percentage of participants | Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 16 | The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. | The Randomized Set (RS) consisted of all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation. | Posted | Number | percentage of participants | Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 48 for Those Achieving PASI75 at Week 16 | The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. | The Week 16 Randomized Set (WK16RS) consisted of all participants who achieved a PASI75 response at Week 16 and were re-randomized into the double-blind, placebo-controlled Maintenance Treatment Period. Missing data were handled using non-response imputation (NRI) methods. | Posted | Number | percentage of participants | Week 48 |
|
Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144.
At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
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 | Placebo Q2W (SS) Wk 0-48 | This arm consisted of all participants who received Placebo (PBO) at any time in the study (Week 0 to Week 48). Only 2 participants received PBO from Week 16 to Week 48. Participants formed the Safety Set (SS). | 0 | 128 | 8 | 128 | 42 | 128 |
| EG001 | Etanercept (SS) Wk 0-12 | This arm consisted of all participants who received Etanercept at any time in the study (Week 0 to Week 12). Participants formed the SS. | 0 | 168 | 1 | 168 | 37 | 168 |
| EG002 | CZP 200 mg Q2W (SS) Wk 0-144 | This arm consisted of all participants who received CZP 200 mg Q2W at any time in the study (Week 0 to Week 144). Participants formed the SS. | 2 | 373 | 34 | 373 | 139 | 373 |
| EG003 | CZP 400 mg Q2W (SS) Wk 0-144 | This arm consisted of all participants who received CZP 400 mg Q2W at any time in the study (Week 0 to Week 144). Participants formed the SS. | 1 | 412 | 51 | 412 | 158 | 412 |
| EG004 | CZP 400mg Q4W (SS) Wk 16-48 | This arm consisted of all participants who received CZP 400 mg Q4W at any time in the study (Week 16 to Week 48). Participants formed the SS. | 0 | 44 | 5 | 44 | 11 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intracardiac mass | Cardiac disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Vestibular disorder | Ear and labyrinth disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Peptic ulcer | Gastrointestinal disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Inflammation | General disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Nodule | General disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Vascular stent thrombosis | General disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Acute hepatic failure | Hepatobiliary disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Sarcoidosis | Immune system disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| House dust allergy | Immune system disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Appendiceal abscess | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Pancreas infection | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Pseudomembranous colitis | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Endophthalmitis | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Pyoderma | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA18.1 | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA18.1 | Non-systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA18.1 | Non-systematic Assessment |
| |
| Extradural haematoma | Injury, poisoning and procedural complications | MedDRA18.1 | Non-systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA18.1 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA18.1 | Non-systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA18.1 | Non-systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA18.1 | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA18.1 | Non-systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA18.1 | Non-systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA18.1 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA18.1 | Non-systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA18.1 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA18.1 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA18.1 | Non-systematic Assessment |
| |
| Mycobacterium tuberculosis complex test negative | Investigations | MedDRA18.1 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA18.1 | Non-systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Sacroiliitis | Musculoskeletal and connective tissue disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Chondropathy | Musculoskeletal and connective tissue disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Anaplastic oligodendroglioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA18.1 | Non-systematic Assessment |
| |
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA18.1 | Non-systematic Assessment |
| |
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA18.1 | Non-systematic Assessment |
| |
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA18.1 | Non-systematic Assessment |
| |
| Clear cell renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA18.1 | Non-systematic Assessment |
| |
| Benign neoplasm of bladder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA18.1 | Non-systematic Assessment |
| |
| Syncope | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA18.1 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Primary progressive multiple sclerosis | Nervous system disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Abortion | Pregnancy, puerperium and perinatal conditions | MedDRA18.1 | Non-systematic Assessment |
| |
| Abortion missed | Pregnancy, puerperium and perinatal conditions | MedDRA18.1 | Non-systematic Assessment |
| |
| Pregnancy on contraceptive | Pregnancy, puerperium and perinatal conditions | MedDRA18.1 | Non-systematic Assessment |
| |
| Bipolar I disorder | Psychiatric disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Urinary bladder haemorrhage | Renal and urinary disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Cervical polyp | Reproductive system and breast disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Rectocele | Reproductive system and breast disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Uterine cyst | Reproductive system and breast disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Erythrodermic psoriasis | Skin and subcutaneous tissue disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Guttate psoriasis | Skin and subcutaneous tissue disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA18.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA18.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA18.1 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | +1844 599 | 2273 | UCBCares@ucb.com |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068582 | Certolizumab Pegol |
| D000068800 | Etanercept |
| 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 |
| D007141 | Immunoglobulin Fc Fragments |
| D007127 | Immunoglobulin Constant Regions |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
Not provided
Not provided
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Did not achieve PASI50 |
|
| Moved out of state |
|
| Sponsor decision due to non-compliance |
|
| Adverse events and alcohol problem |
|
| Patient's decisions |
|
| Unavailability due to business trip |
|
| Withdrawn by Sponsor |
|
| Patient request due to non-compliance |
|
| Death |
|
| Lack of Efficacy |
|
| Protocol Violation |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| No PASI50 response |
|
| No efficacy of study medication |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Black or African American |
|
| White |
|
| Other/mixed |
|
| OG003 | CZP 400 mg Q2W (RS) | CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS). |
| The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure. | Regression, Logistic | Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure. | Estimated difference in responder rate | 56.2 | 2-Sided | 95 | 46.4 | 66.0 | Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS). | Superiority |
| The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure. | Regression, Logistic | Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure. | <0.0001 | The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO. | Odds Ratio (OR) | 37.988 | 2-Sided | 95 | 11.312 | 127.576 | Superiority |
| The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure. | Regression, Logistic | Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure. | <0.0001 | The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO. | Odds Ratio (OR) | 30.023 | 2-Sided | 95 | 8.971 | 100.481 | Superiority |
| The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure. | Regression, Logistic | Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure | Estimated difference in responder rate | 13.4 | 2-Sided | 95 | 2.7 | 24.1 | Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Etanercept Q2W (RS). | Superiority |
| The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure. | Regression, Logistic | Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure | Estimated difference in responder rate | 8.0 | 2-Sided | 95 | -2.9 | 18.9 | Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Etanercept Q2W (RS). | Superiority |
| The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure. | Regression, Logistic | Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure. | =0.0152 | The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. ETN. | Odds Ratio (OR) | 1.756 | 2-Sided | 95 | 1.114 | 2.768 | Superiority |
| The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure. | Regression, Logistic | Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure. | =0.1523 | The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. ETN | Odds Ratio (OR) | 1.388 | 2-Sided | 95 | 0.886 | 2.175 | Superiority |
| OG002 | CZP 200 mg Q2W (RS) | CZP 400 mg injections at Weeks 0, 2, 4, followed by CZP 200 mg every 2 weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W); with Placebo administered on alternate dosing weeks to maintain the blind) Or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS). |
| OG003 | CZP 400 mg Q2W (RS) | CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS). |
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| OG001 | Etanercept (RS) | Etanercept (ETN) 50 mg subcutaneous (sc) injections twice per week throughout Week 11.5. •PASI75 responders at Week 16 were re-randomized to either CZP (loading dose of 400 mg at Weeks 16, 18, and 20 followed by 200 mg Q2W) or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS). |
| OG002 | CZP 200 mg Q2W (RS) | CZP 400 mg injections at Weeks 0, 2, 4, followed by CZP 200 mg every 2 weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W); with Placebo administered on alternate dosing weeks to maintain the blind) Or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS). |
| OG003 | CZP 400 mg Q2W (RS) | CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS). |
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| OG001 | CZP 200 mg Q2W (RS) | CZP 400 mg injections at Weeks 0, 2, 4, followed by CZP 200 mg every 2 weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W); with Placebo administered on alternate dosing weeks to maintain the blind) Or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS). |
| OG002 | CZP 400 mg Q2W (RS) | CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS). |
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| OG002 | CZP 400 mg Q2W (RS) | CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS). |
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| OG001 | CZP 200 mg Q2W (RS) | CZP 400 mg injections at Weeks 0, 2, 4, followed by CZP 200 mg every 2 weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W); with Placebo administered on alternate dosing weeks to maintain the blind) Or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS). |
| OG002 | CZP 400 mg Q2W (RS) | CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS). |
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| OG001 | Etanercept/Placebo Q2W (WK16RS) | This arm consisted of participants initially randomized in the Etanercept arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS). |
| OG002 | Etanercept/CZP 200 mg Q2W (WK16RS) | This arm consisted of participants initially randomized in the Etanercept arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS). |
| OG003 | CZP 200 mg Q2W/Placebo Q2W (WK16RS) | This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS). |
| OG004 | CZP 200 mg Q2W/CZP 200 mg Q2W (WK16RS) | This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS). |
| OG005 | CZP 200 mg Q2W/CZP 400 mg Q4W (WK16RS) | This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q4W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS). |
| OG006 | CZP 400 mg Q2W/Placebo Q2W (WK16RS) | This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS). |
| OG007 | CZP 400 mg Q2W/CZP 200 mg Q2W (WK16RS) | This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS). |
| OG008 | CZP 400 mg Q2W/CZP 400 mg Q2W (WK16RS) | This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS). |
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