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

July 4, 2018 updated by: UCB BIOSCIENCES GmbH

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

409

Phase

  • Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • 700
      • Buenos Aires, Argentina
        • 704
      • Ciudad Autonoma de Buenos Aires, Argentina
        • 707
      • Cordoba, Argentina
        • 705
      • Rosario, Argentina
        • 706
      • San Juan, Argentina
        • 710
      • San Miguel De Tucuman, Argentina
        • 702
      • San Miguel de Tucuman, Argentina
        • 708
  • Belgium
      • Gent, Belgium
        • 152
      • Liege, Belgium
        • 151
  • Brazil
      • Curitiba, Brazil
        • 750
      • Goias, Brazil
        • 757
      • Goiâna, Brazil
        • 761
      • Porto Alegre, Brazil
        • 753
  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada
        • 907
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada
        • 900
    • Ontario
      • Toronto, Ontario, Canada
        • 904
      • Windsor, Ontario, Canada
        • 910
    • Quebec
      • Trois-Rivires, Quebec, Canada
        • 905
  • Czechia
      • Brno, Czechia
        • 504
      • Hlucin, Czechia
        • 501
      • Pardubice, Czechia
        • 500
      • Praha 2, Czechia
        • 502
      • Terezin, Czechia
        • 505
      • Zlin, Czechia
        • 503
  • France
      • Montpellier, France
        • 206
      • Paris, France
        • 204
      • Tours, France
        • 202
  • Germany
      • Bad Nauheim, Germany
        • 252
      • Berlin, Germany
        • 257
      • Berlin, Germany
        • 258
      • Frankfurt, Germany
        • 262
      • Freiburg, Germany
        • 255
      • Hamburg, Germany
        • 254
      • Leipzig, Germany
        • 253
      • München, Germany
        • 263
      • Ratingen, Germany
        • 256
  • Hungary
      • Budapest, Hungary
        • 303
      • Budapest, Hungary
        • 304
      • Debrecen, Hungary
        • 302
      • Gyula, Hungary
        • 301
      • Miskolc, Hungary
        • 306
      • Veszprém, Hungary
        • 300
  • Ireland
      • Dublin 4, Ireland
        • 100
  • Italy
      • Ancona, Italy
        • 352
      • Pisa, Italy
        • 350
  • Mexico
      • Cuernavaca, Mexico
        • 802
      • Mexico D.F., Mexico
        • 803
  • Poland
      • Bialystok, Poland
        • 458
      • Dabrowka, Poland
        • 452
      • Elblag, Poland
        • 455
      • Gdansk, Poland
        • 459
      • Krakow, Poland
        • 457
      • Lublin, Poland
        • 450
      • Poznan, Poland
        • 454
      • Torun, Poland
        • 453
      • Warszawa, Poland
        • 456
      • Warszawa, Poland
        • 462
  • Spain
      • Madrid, Spain
        • 555
      • Mérida, Spain
        • 550
      • Santiago de Compostela, Spain
        • 552
      • Sevilla, Spain
        • 553
  • United Kingdom
      • Barnsley, United Kingdom
        • 605
      • London, United Kingdom
        • 602
      • Salford, United Kingdom
        • 601
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • 961
      • Tuscaloosa, Alabama, United States
        • 953
    • Arizona
      • Peoria, Arizona, United States
        • 954
      • Scottsdale, Arizona, United States
        • 971
    • California
      • Palm Desert, California, United States
        • 966
      • San Diego, California, United States
        • 952
    • Florida
      • Aventura, Florida, United States
        • 957
      • Fort Lauderdale, Florida, United States
        • 962
      • Orange Park, Florida, United States
        • 959
      • Vero Beach, Florida, United States
        • 958
    • Maryland
      • Hagerstown, Maryland, United States
        • 964
    • Michigan
      • Kalamazoo, Michigan, United States
        • 960
    • Minnesota
      • Eagan, Minnesota, United States
        • 969
    • Mississippi
      • Flowood, Mississippi, United States
        • 984
    • Missouri
      • Florissant, Missouri, United States
        • 965
      • Saint Louis, Missouri, United States
        • 950
    • New York
      • Brooklyn, New York, United States
        • 985
    • North Carolina
      • Asheville, North Carolina, United States
        • 963
    • Ohio
      • Cleveland, Ohio, United States
        • 976
      • Middleburg Heights, Ohio, United States
        • 951
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • 970
    • Oregon
      • Portland, Oregon, United States
        • 982
    • Pennsylvania
      • Duncansville, Pennsylvania, United States
        • 972
    • Texas
      • Dallas, Texas, United States
        • 975
      • Houston, Texas, United States
        • 978
      • San Antonio, Texas, United States
        • 967
    • Washington
      • Seattle, Washington, United States
        • 968

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CZP 200 mg Q2W

Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.

At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
Biological: CZP 200 mg Q2W
200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
Other Names:
  • Cimzia
  • Certolizumab Pegol
Other: Placebo
Matching Placebo to CZP injection.
Experimental: CZP 400 mg Q4W

Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.

Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.
Other: Placebo
Matching Placebo to CZP injection.
Biological: CZP 400 mg Q4W
400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
Other Names:
  • Cimzia
  • Certolizumab Pegol
Placebo Comparator: Placebo

Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group 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).
Other: Placebo
Matching Placebo to CZP injection.
Other: Placebo to CZP 200 mg escape on Week 16
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.
Biological: CZP 200 mg Q2W
200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
Other Names:
  • Cimzia
  • Certolizumab Pegol
Other: Placebo
Matching Placebo to CZP injection.
Other: Placebo to CZP 400 mg escape on Week 16
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.
Other: Placebo
Matching Placebo to CZP injection.
Biological: CZP 400 mg Q4W
400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
Other Names:
  • Cimzia
  • Certolizumab Pegol
Other: Placebo to CZP 200 mg on Week 24
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.
Biological: CZP 200 mg Q2W
200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
Other Names:
  • Cimzia
  • Certolizumab Pegol
Other: Placebo
Matching Placebo to CZP injection.
Other: Placebo to CZP 400 mg on Week 24
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.
Other: Placebo
Matching Placebo to CZP injection.
Biological: CZP 400 mg Q4W
400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
Other Names:
  • Cimzia
  • Certolizumab Pegol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American College of Rheumatology 20 (ACR20) Response at Week 12
Time Frame: 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).
Week 12
Change From Baseline in Modified Total Sharp Score (mTSS) in Modification for Psoriatic Arthritis at Week 24
Time Frame: From Baseline to 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.
From Baseline to Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American College of Rheumatology 20 (ACR20) Response at Week 24
Time Frame: 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).
Week 24
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 24
Time Frame: From Baseline to 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.
From Baseline to Week 24
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
Time Frame: Week 24
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.
Week 24
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 48
Time Frame: From Baseline to 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.
From Baseline to Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB BIOSCIENCES GmbH

Investigators

  • Study Director: UCB Clinical Trial Call Center, +1 877 822 9493 UCB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

March 15, 2010

First Submitted That Met QC Criteria

March 15, 2010

First Posted (Estimate)

March 16, 2010

Study Record Updates

Last Update Posted (Actual)

August 1, 2018

Last Update Submitted That Met QC Criteria

July 4, 2018

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PsA001
  • 2009-011720-59 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Arthritis, Psoriatic

Clinical Trials on CZP 200 mg Q2W

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe