Study of CE-224,535 A Twice Daily Pill To Control Rheumatoid Arthritis In Patients Who Have Not Totally Improved With Methotrexate

Pfizer

Status and phase: Completed; Phase 2

Conditions: Arthritis, Rheumatoid

Treatments: Drug: Placebo; Drug: CE-224,535

Study type: Interventional

Funder types: Industry

Identifiers

NCT00628095

A6341009

2008-000327-25 (EudraCT Number)

Details and patient eligibility

About

CE-224,535 is known to block a chemical that acts as a gateway to some of your immune cells. Blocking this gateway prevents the cells from pushing out 2 chemicals called IL-1 and IL-18 that are known to cause some of the inflammation seen in rheumatoid arthritis. It is hoped that taking this drug will reduce the symptoms of rheumatoid arthritis

Enrollment: 100 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Active rheumatoid arthritis
• Incomplete response to methotrexate

Exclusion criteria

• Must not be on biologic therapies
• No recent infections

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Active

Experimental group

Treatment:

Drug: CE-224,535

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo