Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study (OPAL BROADEN)

Pfizer

Status and phase: Completed; Phase 3

Conditions: Psoriatic Arthritis

Treatments: Drug: Adalimumab; Drug: Placebo; Drug: Tofacitinib 5 mg BID; Drug: Tofacitinib 10 mg BID

Study type: Interventional

Funder types: Industry

Identifiers

NCT01877668

A3921091

2011-003668-55 (EudraCT Number)

Details and patient eligibility

About

This is a 12-month study investigating the effectiveness and safety of tofactinib in treating the signs and symptoms of active psoriatic arthritis and improving physical function and preserving bone structure in patients with an inadequate response to a traditional, nonbiologic disease-modifying antirheumatic drug. Adalimumab is used as a comparator.

Enrollment: 422 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females, aged >= 18 years at time of consent.
• Have a diagnosis of Psoriatic arthritis (PsA) of >= 6 months
• Meet the Classification Criteria of PsA (CASPAR) at time of screening
• Must not have been adequately treated with a a traditional non-biologic disease modifying anti-rheumatic drug (DMARD).
• Concurrent treatment with methotrexate, leflunomide, or sulfasalazine allowed and required
• Must not have taken a biologic Tumour Necrosis Factor Inhibitor
• Must have 3 or more swollen joints AND 3 or more tender joints
• Must have active psoriasis skin lesions

Exclusion criteria

• Have non-plaque forms of psoriasis, eg erythrodermic, guttate or pustular, with the exception of nail psoriasis which is allowed
• Pregnant or breast feeding, females of child-bearing potential not using highly effective contraception
• New York Heart Association Class III and IV congestive heart failure
• History of hypersensitivity or infusion reaction to biologic agents
• Infection with HIV, hepatitis B virus, hepatitis C virus, or other chronic infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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422 participants in 5 patient groups, including a placebo group

Tofacitinib 5 mgBID x 12 months

Experimental group

Treatment:

Drug: Tofacitinib 5 mg BID

Tofacitinib 10 mg BID x 12 months

Experimental group

Treatment:

Drug: Tofacitinib 10 mg BID

Adalimumab 40 mg q2 weeks x 12 months

Active Comparator group

Treatment:

Drug: Adalimumab

Placebo x3 months, then tofacitinib 5 mg BIDx 9 months

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Placebo x 3 months, then tofacitinib 10 mg BID x 9 months

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo