Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate

Pfizer

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: PF-06651600; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02969044

2016-002862-30 (EudraCT Number)

B7981006

Details and patient eligibility

About

This is an 8 week study to assess the efficacy and safety profile of PF-06651600 in seropositive subjects with rheumatoid arthritis with an inadequate response to methotrexate (up to approximately 50% of subjects may also have had an inadequate response to 1 anti-TNF biologic).

Enrollment: 70 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Subjects between the ages of 18 and 75 years, inclusive
• Must have moderate-to-severe, active Rheumatoid Arthritis
• Must have had an inadequate response to Methotrexate
• Subjects may have received one approved TNF inhibiting biologic agent that was inadequately effective and/or not tolerated

Exclusion Criteria

• Subjects with any acute or chronic infections or infection history
• Have acute or active chronic dermatological disorders prior to study start
• Any major illness/condition(s) or evidence of an unstable clinical condition that in the judgment of the investigator would make the subject inappropriate for entry into this study
• Known immunodeficiency disorder or a first degree relative with hereditary immunodeficiency
• Any live (attenuated) vaccines or current routine household contact with anyone who has received live (attenuated) vaccine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

PF-06651600

Experimental group

Description:

Study Drug

Treatment:

Drug: PF-06651600

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo