Study To Evaluate The Pharmacokinetic Interaction Between PLA-695 And Methotrexate In Adults With Rheumatoid Arthritis

Wyeth

Status and phase: Completed; Phase 1

Conditions: Arthritis, Rheumatoid

Treatments: Drug: PLA-695

Study type: Interventional

Funder types: Industry

Identifiers

NCT00440492

3175A3-104

Details and patient eligibility

About

The purpose of this study is to determine if PLA-695 changes the blood concentrations of methotrexate when administered together.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men or women of nonchildbearing potential with rheumatoid arthritis (RA), aged 18 to 75 years
• RA disease onset after 16 years of age and has had the disease for at least 6 months
• Must be receiving a stable, well-tolerated oral dose of methotrexate (5 to 25 mg) taken once weekly for at least 3 months

Exclusion criteria

• Evidence of unstable clinically significant disease

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)