Phase 3 N=409 Randomized Double-blind Treatment

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

Arthritis, Psoriatic

Bottom Line

View on ClinicalTrials.gov: NCT01087788 ↗

Enrolled (actual)

409

Serious AEs

25.5%

Results posted

Feb 2014

Primary outcome: Primary: American College of Rheumatology 20 (ACR20) Response at Week 12 — 24.3; 58.0; 51.9 percentage of participants — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: CZP 200 mg Q2W (Biological); CZP 400 mg Q4W (Biological); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: UCB BIOSCIENCES GmbH
Primary completion: Nov 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY American College of Rheumatology 20 (ACR20) Response at Week 12	24.3; 58.0; 51.9	<0.001 sig
PRIMARY Change From Baseline in Modified Total Sharp Score (mTSS) in Modification for Psoriatic Arthritis at Week 24	28.92; 11.52; 25.05; 18.28; 0.18; -0.02	=0.203
SECONDARY American College of Rheumatology 20 (ACR20) Response at Week 24	23.5; 63.8; 56.3	<0.001 sig
SECONDARY Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 24	-0.19; -0.54; -0.46; -0.50	<0.001 sig
SECONDARY 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	15.1; 62.2; 60.5; 61.4	<0.001 sig
SECONDARY Change From Baseline in Modified Total Sharp Score (mTSS) at Week 48	0.32; 0.15; 0.11; 0.13; 0.78; 0.31	=0.127

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).

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

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Data sourced from ClinicalTrials.gov (NCT01087788). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.