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

Phase 3

Completed

• Conditions: Arthritis, Psoriatic

• Registration Number: NCT01087788
• Lead Sponsor: UCB BIOSCIENCES GmbH

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-15
• Study First Submitted QC: 2010-03-15
• Study First Posted: 2010-03-16
• Primary Completion: 2011-11
• Disposition First Submitted: 2012-08-09
• Disposition First Submitted QC: 2012-08-09
• Disposition First Posted: 2012-08-17
• Results First Submitted: 2013-10-25
• Results First Submitted QC: 2014-01-07
• Results First Posted: 2014-02-25
• Study Completion: 2015-08
• Status Verified: 2017-01
• Last Update Submitted: 2018-07-04
• Last Update Posted: 2018-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 409

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Modified Total Sharp Score (mTSS) in Modification for Psoriatic Arthritis at Week 24	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.
American College of Rheumatology 20 (ACR20) Response at Week 12	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).

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 48	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.
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	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.
American College of Rheumatology 20 (ACR20) Response at Week 24	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	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.

Trial Locations

Locations (92)

961; 🇺🇸 Birmingham, Alabama, United States

953; 🇺🇸 Tuscaloosa, Alabama, United States

954; 🇺🇸 Peoria, Arizona, United States

971; 🇺🇸 Scottsdale, Arizona, United States

966; 🇺🇸 Palm Desert, California, United States

952; 🇺🇸 San Diego, California, United States

957; 🇺🇸 Aventura, Florida, United States

962; 🇺🇸 Fort Lauderdale, Florida, United States

959; 🇺🇸 Orange Park, Florida, United States

958; 🇺🇸 Vero Beach, Florida, United States

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