Study Evaluating Efficacy / Safety of Etanercept + Methotrexate Compared to Usual Treatment in Moderate RA Subjects

Wyeth

Status and phase: Terminated; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: etanercept (EnbrelTM); Drug: methotrexate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00706797

0881X1-4437

Details and patient eligibility

About

To assess comparative radiographic efficacy, clinical efficacy and safety of etanercept (ETN) + methotrexate (MTX) with usual disease-modifying anti-rheumatic drug (DMARD) treatment in subjects with moderate RA who were treated with MTX monotherapy, but continue to have moderate disease activity.

Enrollment: 141 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meet the 1987 ACR Revised Criteria for Rheumatoid Arthritis.
• Documented evidence, confirmed by a blinded 3rd party assessor, of at least one erosion observed by X-ray at randomization based on X-ray taken at the screening visit.
• Have received MTX as stable dose for 28 days prior to the screening visit.

Exclusion criteria

• Previous treatment with ETN, infliximab, adalimumab, other Tumor necrosis factor (TNF) -a inhibitors, anakinra or other biological agents.
• Receipt of any DMARD, other than MTX, within 28 days before screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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141 participants in 2 patient groups

Usual care

Active Comparator group

Description:

Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).

Treatment:

Drug: methotrexate

ETN + MTX

Active Comparator group

Description:

Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).

Treatment:

Drug: etanercept (EnbrelTM)

Drug: methotrexate