Study Conducted in Subjects With Rheumatoid Arthritis Who Have Moderate to Severe Disease Activity Despite Methotrexate Therapy With or Without Other Non Biologic Disease Modifying Antirheumatic Drugs (DMARDs)for at Least 12 Weeks Prior to Screening

Pfizer

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: Etanercept; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01578850

B1801315 (Other Identifier)

2011-005448-87 (EudraCT Number)

Details and patient eligibility

About

To compare the maintenance of efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with or without other disease modifying antirheumatic drugs therapy with that of methotrexate with or without other disease modifying antirheumatic drugs therapy at Week 52 in subjects with moderately to severely active rheumatoid arthritis who have achieved low disease activity after 24 weeks of therapy with open label etanercept 50 mg once weekly plus MTX with or without other disease modifying antirheumatic drugs therapy.

Enrollment: 491 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject has a minimum 1 year history/diagnosis of rheumatoid arthritis based on the 1987 American College of Rheumatology (ACR) Revised criteria for RA.
2. Subject must have active rheumatoid arthritis despite methotrexate (MTX) therapy of ≥10 mg/wk for at least 12 weeks. The MTX dose must be stable for at least 4 weeks immediately prior to screening.

Exclusion criteria

1. Subjects who used any of the following systemic treatments during the washout periods given below:

   1. Oral corticosteroid dose of prednisone >7.5 mg/day (or equivalent) or a change in dose within 28 days of baseline.
   2. Treatment with more than 1 NSAID within 14 days at baseline.
   3. Methotrexate dose greater than 25 mg/week, or change in the dose of methotrexate within 28 days of baseline.
   4. Subjects will be allowed to continue the following non biologic DMARDs: sulfasalazine, hydroxychloroquine, and leflumomide. All other non-biologic DMARDs (including but not limited to gold, penicillamine, azathioprine, cyclophospamide), and biologic DMARDs must have been discontinued at least 2 months prior to Week 1.
   5. Any biologic B cell depleting agent (eg, rituximab) within 2 years of Week 1.

2. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.

3. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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491 participants in 2 patient groups, including a placebo group

Group A

Experimental group

Treatment:

Drug: Etanercept

Group B

Placebo Comparator group

Treatment:

Drug: placebo