A Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis

Pfizer

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: PF-04171327 25 mg; Other: Prednisone Placebo; Other: Placebo; Drug: Prednisone 5 mg; Drug: PF-04171327 10 mg; Other: Placebo for PF-04171327

Study type: Interventional

Funder types: Industry

Identifiers

NCT00938587

2009-013223-37 (EudraCT Number)

A9391005

Details and patient eligibility

About

This study will investigate the safety and efficacy of an investigational drug, PF-04171327 on the signs and symptoms of rheumatoid arthritis in patients that require glucocorticoids while on background methotrexate. This study will also look at the response of chemical and biological markers in rheumatoid arthritis patients. Lastly, this study will measure the PK (amount of drug in the blood) of methotrexate while patients may be taking PF-04171327.

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients ≥ 18 years of age, diagnosed with rheumatoid arthritis for a minimum duration of 3 months
• On stable dose of methotrexate for at least 6 weeks prior to screening
• Patient must have minimum disease activity level of ≥ 6 tender/painful joints, ≥ 6 swollen joints and CRP ≥ 0.7 mg/dL
• Not currently receiving steroid medication

Exclusion criteria

• Pregnant or nursing women
• Patients that have active infections, TB, HIV and/or Hepatitis B or C
• Patients that have a history of intolerance or significant adverse effects with the use of glucocorticoids

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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86 participants in 4 patient groups, including a placebo group

PF-04171327 10 mg

Experimental group

Treatment:

Drug: PF-04171327 10 mg

Other: Prednisone Placebo

Other: Prednisone Placebo

PF-04171327 25 mg

Experimental group

Treatment:

Drug: PF-04171327 25 mg

Other: Prednisone Placebo

Other: Prednisone Placebo

Prednisone

Active Comparator group

Treatment:

Other: Placebo for PF-04171327

Other: Placebo for PF-04171327

Drug: Prednisone 5 mg

Placebo

Placebo Comparator group

Treatment:

Other: Placebo for PF-04171327

Other: Placebo

Other: Placebo for PF-04171327