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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 <

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 Summary:
Sponsor: UCB BIOSCIENCES GmbH

Current Primary Outcome:

• 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).
• 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.

Original Primary Outcome:

• American College of Rheumatology 20 (ACR20) response [ Time Frame: Week 12 ]
• modified Total Sharp Score (mTSS) change from baseline [ Time Frame: Week 24 ]

Current Secondary Outcome:

• 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).
• 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.
• 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.
• 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.

Original Secondary Outcome:

• American College of Rheumatology 20 (ACR20) response [ Time Frame: Week 24 ]
• Health Assessment Questionnaire - Disability Index (HAQ-DI) change from baseline [ Time Frame: Week 12, Week 24, Week 48 ]
• modified Total Sharp Score (mTSS) change from baseline [ Time Frame: Week 48 ]
• Psoriasis Area Severity Index (PASI75) response in the subgroup of subjects with Psoriasis (PSO) involving at least 3% Body Surface Area (BSA) at Baseline [ Time Frame: Week 12, Week 24 ]

Dates:
Date Received: March 15, 2010
Date Started: March 2010
Date Completion:
Last Updated: January 17, 2017
Last Verified: January 2017