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

UCB

Status and phase: Completed; Phase 3

Conditions: Arthritis, Psoriatic

Treatments: Biological: CZP 200 mg Q2W; Other: Placebo; Biological: CZP 400 mg Q4W

Study type: Interventional

Funder types: Industry

Identifiers

NCT01087788

PsA001

2009-011720-59 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 409 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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409 participants in 7 patient groups, including a placebo group

CZP 200 mg Q2W

Experimental group

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.

Treatment:

Other: Placebo

Biological: CZP 200 mg Q2W

CZP 400 mg Q4W

Experimental group

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.

Treatment:

Biological: CZP 400 mg Q4W

Other: Placebo

Placebo

Placebo Comparator group

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).

Treatment:

Other: Placebo

Placebo to CZP 200 mg escape on Week 16

Other group

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.

Treatment:

Other: Placebo

Biological: CZP 200 mg Q2W

Placebo to CZP 400 mg escape on Week 16

Other group

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.

Treatment:

Biological: CZP 400 mg Q4W

Other: Placebo

Placebo to CZP 200 mg on Week 24

Other group

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.

Treatment:

Other: Placebo

Biological: CZP 200 mg Q2W

Placebo to CZP 400 mg on Week 24

Other group

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.

Treatment:

Biological: CZP 400 mg Q4W

Other: Placebo