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Certolizumab Pegol in Subjects With Adult Onset Active and Progressive Psoriatic Arthritis

Primary Purpose

Arthritis, Psoriatic

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CZP 200 mg Q2W
CZP 400 mg Q4W
Placebo
Sponsored by
UCB BIOSCIENCES GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Psoriatic focused on measuring Certolizumab Pegol, Cimzia

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of adult-onset Psoriatic Arthritis (PsA) of at least 6 months' duration as defined by the Classification Criteria for Psoriatic Arthritis (CASPAR criteria)
  • Active Psoriatic Skin Lesions or a documented history of Psoriasis

  • Active Arthritis with ≥ 3 tender joints at Screening and Baseline, ≥ 3 swollen joints at Screening and Baseline and fulfilling at least 1 of the following 2 criteria during the Screening Period:

    1. Erythrocyte Sedimentation Rate (ESR) (Westergren) ≥ 28 mm/hour
    2. C-reactive protein (CRP) > Upper Limit Normal (ULN)
  • Failure to 1 or more treatment with Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

Exclusion Criteria:

  • Diagnosis of any other inflammatory Arthritis or known diagnosis of Fibromyalgia
  • Exposure to more than 1 Tumor Necrosis Factor α (TNFα) antagonist or to more than 2 previous biological response modifiers for PsA or Psoriasis
  • Any non-biological systemic treatment of Psoriasis; phototherapy; topical agents
  • History of chronic or recurrent infections
  • High risk of infection
  • Live vaccination within the 8 weeks prior to Baseline
  • Concurrent malignancy or a history of malignancy
  • Class III or IV congestive Heart Failure - New York Heart Association (NYHA)
  • Demyelinating disease of the central nervous system
  • Clinically significant laboratory abnormalities

Sites / Locations

  • 961
  • 953
  • 954
  • 971
  • 966
  • 952
  • 957
  • 962
  • 959
  • 958
  • 964
  • 960
  • 969
  • 984
  • 965
  • 950
  • 985
  • 963
  • 976
  • 951
  • 970
  • 982
  • 972
  • 975
  • 978
  • 967
  • 968
  • 700
  • 704
  • 707
  • 705
  • 706
  • 710
  • 702
  • 708
  • 152
  • 151
  • 750
  • 757
  • 761
  • 753
  • 907
  • 900
  • 904
  • 910
  • 905
  • 504
  • 501
  • 500
  • 502
  • 505
  • 503
  • 206
  • 204
  • 202
  • 252
  • 257
  • 258
  • 262
  • 255
  • 254
  • 253
  • 263
  • 256
  • 303
  • 304
  • 302
  • 301
  • 306
  • 300
  • 100
  • 352
  • 350
  • 802
  • 803
  • 458
  • 452
  • 455
  • 459
  • 457
  • 450
  • 454
  • 453
  • 456
  • 462
  • 555
  • 550
  • 552
  • 553
  • 605
  • 602
  • 601

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Placebo Comparator

Other

Other

Other

Other

Arm Label

CZP 200 mg Q2W

CZP 400 mg Q4W

Placebo

Placebo to CZP 200 mg escape on Week 16

Placebo to CZP 400 mg escape on Week 16

Placebo to CZP 200 mg on Week 24

Placebo to CZP 400 mg on Week 24

Arm Description

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.

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.

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 and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16. After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

American College of Rheumatology 20 (ACR20) Response at Week 12
ACR20 responders are those subjects with at least 20 % improvement from Baseline (BL) for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS).
Change From Baseline in Modified Total Sharp Score (mTSS) in Modification for Psoriatic Arthritis at Week 24
Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 64 and 52 joints, respectively, with higher scores representing greater damage. mTSS (bone erosions) ranges from 0 (best possible outcome) to 320 (worst possible outcome); mTSS (joint space narrowing) ranges from 0 (best possible outcome) to 208 (worst possible outcome); and total score ranges from 0 (best possible outcome) to 528 (worst possible outcome). For the pre-defined analysis of this outcome measure, 0 was used for Baseline and the maximum observed mTSS value was used for Week 24 for those subjects which had less than 2 radiographs. The re-analysis is restricted to those subjects in the Randomized Set who have at least 2 x-ray values at scheduled visits, which are at least 8 weeks apart.

Secondary Outcome Measures

American College of Rheumatology 20 (ACR20) Response at Week 24
ACR20 responders are those subjects with at least 20 % improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS).
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 24
The HAQ-DI is a measure of function in Arthritis. There are 20 items in eight categories that represent a comprehensive set of functional activities on a scale from 0 (without difficulty) to 3 (unable to perform without assistance). The category scores are averaged into an overall HAQ-DI from 0 to 3. Scores of 0 to 1 generally represent mild to moderate difficulty, 1 to 2 represent moderate to severe disability, and 2 to 3 indicate severe to very severe disability. A negative value in HAQ-DI change from Baseline indicates an improvement from Baseline. The higher the negative value, the higher the improvement.
Psoriasis Area Severity Index (PASI75) Response at Week 24 in the Subgroup of Subjects With Psoriasis (PSO) Involving at Least 3 % Body Surface Area (BSA) at Baseline
The PASI75 response assessments are based on at least 75 % improvement in the PASI score from Baseline. The PASI score is a measure of the average redness, thickness, and scaliness of the psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement.
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 48
Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 64 and 52 joints, respectively, with higher scores representing greater damage. mTSS (bone erosions) ranges from 0 (best possible outcome) to 320 (worst possible outcome); mTSS (joint space narrowing) ranges from 0 (best possible outcome) to 208 (worst possible outcome); and total score ranges from 0 (best possible outcome) to 528 (worst possible outcome). For the analysis of this outcome measure, the change from Baseline to Week 48 was imputed using the median change from Baseline among all subjects for those subjects, which had less than 2 radiographs. The post-hoc analysis presented here is based on the subgroup of subjects which had a Baseline mTSS value greater than 6.

Full Information

First Posted
March 15, 2010
Last Updated
July 4, 2018
Sponsor
UCB BIOSCIENCES GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01087788
Brief Title
Certolizumab Pegol in Subjects With Adult Onset Active and Progressive Psoriatic Arthritis
Official Title
Phase 3, Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Subjects With Adult-Onset Active and Progressive Psoriatic Arthritis (PsA)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB BIOSCIENCES GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in subjects with adult onset active and progressive Psoriatic Arthritis (PsA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Psoriatic
Keywords
Certolizumab Pegol, Cimzia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
409 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CZP 200 mg Q2W
Arm Type
Experimental
Arm Description
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.
Arm Title
CZP 400 mg Q4W
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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 and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16. After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).
Arm Title
Placebo to CZP 200 mg escape on Week 16
Arm Type
Other
Arm Description
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.
Arm Title
Placebo to CZP 400 mg escape on Week 16
Arm Type
Other
Arm Description
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.
Arm Title
Placebo to CZP 200 mg on Week 24
Arm Type
Other
Arm Description
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.
Arm Title
Placebo to CZP 400 mg on Week 24
Arm Type
Other
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
CZP 200 mg Q2W
Other Intervention Name(s)
Cimzia, Certolizumab Pegol
Intervention Description
200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
Intervention Type
Biological
Intervention Name(s)
CZP 400 mg Q4W
Other Intervention Name(s)
Cimzia, Certolizumab Pegol
Intervention Description
400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo to CZP injection.
Primary Outcome Measure Information:
Title
American College of Rheumatology 20 (ACR20) Response at Week 12
Description
ACR20 responders are those subjects with at least 20 % improvement from Baseline (BL) for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS).
Time Frame
Week 12
Title
Change From Baseline in Modified Total Sharp Score (mTSS) in Modification for Psoriatic Arthritis at Week 24
Description
Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 64 and 52 joints, respectively, with higher scores representing greater damage. mTSS (bone erosions) ranges from 0 (best possible outcome) to 320 (worst possible outcome); mTSS (joint space narrowing) ranges from 0 (best possible outcome) to 208 (worst possible outcome); and total score ranges from 0 (best possible outcome) to 528 (worst possible outcome). For the pre-defined analysis of this outcome measure, 0 was used for Baseline and the maximum observed mTSS value was used for Week 24 for those subjects which had less than 2 radiographs. The re-analysis is restricted to those subjects in the Randomized Set who have at least 2 x-ray values at scheduled visits, which are at least 8 weeks apart.
Time Frame
From Baseline to Week 24
Secondary Outcome Measure Information:
Title
American College of Rheumatology 20 (ACR20) Response at Week 24
Description
ACR20 responders are those subjects with at least 20 % improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS).
Time Frame
Week 24
Title
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 24
Description
The HAQ-DI is a measure of function in Arthritis. There are 20 items in eight categories that represent a comprehensive set of functional activities on a scale from 0 (without difficulty) to 3 (unable to perform without assistance). The category scores are averaged into an overall HAQ-DI from 0 to 3. Scores of 0 to 1 generally represent mild to moderate difficulty, 1 to 2 represent moderate to severe disability, and 2 to 3 indicate severe to very severe disability. A negative value in HAQ-DI change from Baseline indicates an improvement from Baseline. The higher the negative value, the higher the improvement.
Time Frame
From Baseline to Week 24
Title
Psoriasis Area Severity Index (PASI75) Response at Week 24 in the Subgroup of Subjects With Psoriasis (PSO) Involving at Least 3 % Body Surface Area (BSA) at Baseline
Description
The PASI75 response assessments are based on at least 75 % improvement in the PASI score from Baseline. The PASI score is a measure of the average redness, thickness, and scaliness of the psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement.
Time Frame
Week 24
Title
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 48
Description
Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 64 and 52 joints, respectively, with higher scores representing greater damage. mTSS (bone erosions) ranges from 0 (best possible outcome) to 320 (worst possible outcome); mTSS (joint space narrowing) ranges from 0 (best possible outcome) to 208 (worst possible outcome); and total score ranges from 0 (best possible outcome) to 528 (worst possible outcome). For the analysis of this outcome measure, the change from Baseline to Week 48 was imputed using the median change from Baseline among all subjects for those subjects, which had less than 2 radiographs. The post-hoc analysis presented here is based on the subgroup of subjects which had a Baseline mTSS value greater than 6.
Time Frame
From Baseline to Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of adult-onset Psoriatic Arthritis (PsA) of at least 6 months' duration as defined by the Classification Criteria for Psoriatic Arthritis (CASPAR criteria) Active Psoriatic Skin Lesions or a documented history of Psoriasis Active Arthritis with ≥ 3 tender joints at Screening and Baseline, ≥ 3 swollen joints at Screening and Baseline and fulfilling at least 1 of the following 2 criteria during the Screening Period: Erythrocyte Sedimentation Rate (ESR) (Westergren) ≥ 28 mm/hour C-reactive protein (CRP) > Upper Limit Normal (ULN) Failure to 1 or more treatment with Disease-Modifying Anti-Rheumatic Drugs (DMARDs) Exclusion Criteria: Diagnosis of any other inflammatory Arthritis or known diagnosis of Fibromyalgia Exposure to more than 1 Tumor Necrosis Factor α (TNFα) antagonist or to more than 2 previous biological response modifiers for PsA or Psoriasis Any non-biological systemic treatment of Psoriasis; phototherapy; topical agents History of chronic or recurrent infections High risk of infection Live vaccination within the 8 weeks prior to Baseline Concurrent malignancy or a history of malignancy Class III or IV congestive Heart Failure - New York Heart Association (NYHA) Demyelinating disease of the central nervous system Clinically significant laboratory abnormalities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 UCB
Official's Role
Study Director
Facility Information:
Facility Name
961
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
953
City
Tuscaloosa
State/Province
Alabama
Country
United States
Facility Name
954
City
Peoria
State/Province
Arizona
Country
United States
Facility Name
971
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
966
City
Palm Desert
State/Province
California
Country
United States
Facility Name
952
City
San Diego
State/Province
California
Country
United States
Facility Name
957
City
Aventura
State/Province
Florida
Country
United States
Facility Name
962
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
959
City
Orange Park
State/Province
Florida
Country
United States
Facility Name
958
City
Vero Beach
State/Province
Florida
Country
United States
Facility Name
964
City
Hagerstown
State/Province
Maryland
Country
United States
Facility Name
960
City
Kalamazoo
State/Province
Michigan
Country
United States
Facility Name
969
City
Eagan
State/Province
Minnesota
Country
United States
Facility Name
984
City
Flowood
State/Province
Mississippi
Country
United States
Facility Name
965
City
Florissant
State/Province
Missouri
Country
United States
Facility Name
950
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
985
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
963
City
Asheville
State/Province
North Carolina
Country
United States
Facility Name
976
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
951
City
Middleburg Heights
State/Province
Ohio
Country
United States
Facility Name
970
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
982
City
Portland
State/Province
Oregon
Country
United States
Facility Name
972
City
Duncansville
State/Province
Pennsylvania
Country
United States
Facility Name
975
City
Dallas
State/Province
Texas
Country
United States
Facility Name
978
City
Houston
State/Province
Texas
Country
United States
Facility Name
967
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
968
City
Seattle
State/Province
Washington
Country
United States
Facility Name
700
City
Buenos Aires
Country
Argentina
Facility Name
704
City
Buenos Aires
Country
Argentina
Facility Name
707
City
Ciudad Autonoma de Buenos Aires
Country
Argentina
Facility Name
705
City
Cordoba
Country
Argentina
Facility Name
706
City
Rosario
Country
Argentina
Facility Name
710
City
San Juan
Country
Argentina
Facility Name
702
City
San Miguel De Tucuman
Country
Argentina
Facility Name
708
City
San Miguel de Tucuman
Country
Argentina
Facility Name
152
City
Gent
Country
Belgium
Facility Name
151
City
Liege
Country
Belgium
Facility Name
750
City
Curitiba
Country
Brazil
Facility Name
757
City
Goias
Country
Brazil
Facility Name
761
City
Goiâna
Country
Brazil
Facility Name
753
City
Porto Alegre
Country
Brazil
Facility Name
907
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
900
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
904
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
910
City
Windsor
State/Province
Ontario
Country
Canada
Facility Name
905
City
Trois-Rivires
State/Province
Quebec
Country
Canada
Facility Name
504
City
Brno
Country
Czechia
Facility Name
501
City
Hlucin
Country
Czechia
Facility Name
500
City
Pardubice
Country
Czechia
Facility Name
502
City
Praha 2
Country
Czechia
Facility Name
505
City
Terezin
Country
Czechia
Facility Name
503
City
Zlin
Country
Czechia
Facility Name
206
City
Montpellier
Country
France
Facility Name
204
City
Paris
Country
France
Facility Name
202
City
Tours
Country
France
Facility Name
252
City
Bad Nauheim
Country
Germany
Facility Name
257
City
Berlin
Country
Germany
Facility Name
258
City
Berlin
Country
Germany
Facility Name
262
City
Frankfurt
Country
Germany
Facility Name
255
City
Freiburg
Country
Germany
Facility Name
254
City
Hamburg
Country
Germany
Facility Name
253
City
Leipzig
Country
Germany
Facility Name
263
City
München
Country
Germany
Facility Name
256
City
Ratingen
Country
Germany
Facility Name
303
City
Budapest
Country
Hungary
Facility Name
304
City
Budapest
Country
Hungary
Facility Name
302
City
Debrecen
Country
Hungary
Facility Name
301
City
Gyula
Country
Hungary
Facility Name
306
City
Miskolc
Country
Hungary
Facility Name
300
City
Veszprém
Country
Hungary
Facility Name
100
City
Dublin 4
Country
Ireland
Facility Name
352
City
Ancona
Country
Italy
Facility Name
350
City
Pisa
Country
Italy
Facility Name
802
City
Cuernavaca
Country
Mexico
Facility Name
803
City
Mexico D.F.
Country
Mexico
Facility Name
458
City
Bialystok
Country
Poland
Facility Name
452
City
Dabrowka
Country
Poland
Facility Name
455
City
Elblag
Country
Poland
Facility Name
459
City
Gdansk
Country
Poland
Facility Name
457
City
Krakow
Country
Poland
Facility Name
450
City
Lublin
Country
Poland
Facility Name
454
City
Poznan
Country
Poland
Facility Name
453
City
Torun
Country
Poland
Facility Name
456
City
Warszawa
Country
Poland
Facility Name
462
City
Warszawa
Country
Poland
Facility Name
555
City
Madrid
Country
Spain
Facility Name
550
City
Mérida
Country
Spain
Facility Name
552
City
Santiago de Compostela
Country
Spain
Facility Name
553
City
Sevilla
Country
Spain
Facility Name
605
City
Barnsley
Country
United Kingdom
Facility Name
602
City
London
Country
United Kingdom
Facility Name
601
City
Salford
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23942868
Citation
Mease PJ, Fleischmann R, Deodhar AA, Wollenhaupt J, Khraishi M, Kielar D, Woltering F, Stach C, Hoepken B, Arledge T, van der Heijde D. Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a Phase 3 double-blind randomised placebo-controlled study (RAPID-PsA). Ann Rheum Dis. 2014 Jan;73(1):48-55. doi: 10.1136/annrheumdis-2013-203696. Epub 2013 Aug 13.
Results Reference
result
PubMed Identifier
23942869
Citation
van der Heijde D, Fleischmann R, Wollenhaupt J, Deodhar A, Kielar D, Woltering F, Stach C, Hoepken B, Arledge T, Mease PJ. Effect of different imputation approaches on the evaluation of radiographic progression in patients with psoriatic arthritis: results of the RAPID-PsA 24-week phase III double-blind randomised placebo-controlled study of certolizumab pegol. Ann Rheum Dis. 2014 Jan;73(1):233-7. doi: 10.1136/annrheumdis-2013-203697. Epub 2013 Aug 13.
Results Reference
result
PubMed Identifier
29556416
Citation
van der Heijde D, Deodhar A, FitzGerald O, Fleischmann R, Gladman D, Gottlieb AB, Hoepken B, Bauer L, Irvin-Sellers O, Khraishi M, Peterson L, Turkiewicz A, Wollenhaupt J, Mease PJ. 4-year results from the RAPID-PsA phase 3 randomised placebo-controlled trial of certolizumab pegol in psoriatic arthritis. RMD Open. 2018 Mar 14;4(1):e000582. doi: 10.1136/rmdopen-2017-000582. eCollection 2018. Erratum In: RMD Open. 2018 Mar 26;4(1):
Results Reference
result
PubMed Identifier
30191421
Citation
Walsh JA, Gottlieb AB, Hoepken B, Nurminen T, Mease PJ. Efficacy of certolizumab pegol with and without concomitant use of disease-modifying anti-rheumatic drugs over 4 years in psoriatic arthritis patients: results from the RAPID-PsA randomized controlled trial. Clin Rheumatol. 2018 Dec;37(12):3285-3296. doi: 10.1007/s10067-018-4227-7. Epub 2018 Sep 6. Erratum In: Clin Rheumatol. 2018 Oct 11;:
Results Reference
derived
PubMed Identifier
27696727
Citation
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.
Results Reference
derived
PubMed Identifier
24996416
Citation
Osterhaus JT, Purcaru O. Discriminant validity, responsiveness and reliability of the arthritis-specific Work Productivity Survey assessing workplace and household productivity in patients with psoriatic arthritis. Arthritis Res Ther. 2014 Jul 4;16(4):R140. doi: 10.1186/ar4602.
Results Reference
derived
PubMed Identifier
24942382
Citation
Kavanaugh A, Gladman D, van der Heijde D, Purcaru O, Mease P. Improvements in productivity at paid work and within the household, and increased participation in daily activities after 24 weeks of certolizumab pegol treatment of patients with psoriatic arthritis: results of a phase 3 double-blind randomised placebo-controlled study. Ann Rheum Dis. 2015 Jan;74(1):44-51. doi: 10.1136/annrheumdis-2014-205198. Epub 2014 Jun 18.
Results Reference
derived
PubMed Identifier
24339179
Citation
Gladman D, Fleischmann R, Coteur G, Woltering F, Mease PJ. Effect of certolizumab pegol on multiple facets of psoriatic arthritis as reported by patients: 24-week patient-reported outcome results of a phase III, multicenter study. Arthritis Care Res (Hoboken). 2014 Jul;66(7):1085-92. doi: 10.1002/acr.22256.
Results Reference
derived
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

Certolizumab Pegol in Subjects With Adult Onset Active and Progressive Psoriatic Arthritis

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