Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study

Conditions

• Psoriatic Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tofacitinib 5 mg BID — DRUG
  Tofacitinib orally (po) 1 tablet of 5 mg and placebo po 1 tablet BID x 12 months Placebo injections subcu every 2 weeks x 12 months
• Tofacitinib 10 mg BID — DRUG
  Tofacitinib po 2 tablets of 5 mg BID x 12 months Placebo injections subcu every 2 weeks x 12 months
• Adalimumab — DRUG
  Placebo po 2 tablets BIDx 12 months Adalimumab 40 mg subcu injections every 2 weeks x 12 months
• Placebo — DRUG
  Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 1 tablet of 5 mg and placebo po 1 tablet BID x 9 months Placebo injections every 2 weeks x 12 months
• Placebo — DRUG
  Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 2 tablets (5 mg) BID x 9 months Placebo injections every 2 weeks x 12 months

Study Details

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.

Key Dates

Start date

Jan 20, 2014

Status verified

Jun 2017

Primary completion

Dec 18, 2015

Completion

Dec 18, 2015

Study Design

Enrollment

422 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Tofacitinib 5 mgBID x 12 months
• Experimental: Tofacitinib 10 mg BID x 12 months
• Active Comparator: Adalimumab 40 mg q2 weeks x 12 months
• Placebo Comparator: Placebo x3 months, then tofacitinib 5 mg BIDx 9 months
• Placebo Comparator: Placebo x 3 months, then tofacitinib 10 mg BID x 9 months

Primary Outcome Measure

Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20): Month 3 [ Time Frame: At end of Month 3 ]

Locations (24)

Find similar trials in Birmingham, AL

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