Study Comparing The Effect On Disease Activity When Reducing Or Discontinuing Etanercept In Subjects With RA (DOSERA)

Pfizer

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: Etanercept; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00858780

B1801016

0881K1-4500

Details and patient eligibility

About

This study involves Rheumatoid Arthritis patients in regular clinical setting who are already on etanercept treatment and are in remission or in a low disease activity (LDA) state, and is intended to identify parameters that can serve as guidance in clinical settings. This study will consider the clinical and radiographic course in subjects when etanercept treatment is tapered or discontinued, and analyze the subjects' experience of disease worsening and the predictive values of clinical parameters, serum biomarkers and imaging on the clinical and radiographic course in different treatment groups. The effect of re-treatment with etanercept at treatment failure will also be studied.

Enrollment: 91 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has a current DAS28 equal to or less than 3.2.
• Subject is currently receiving treatment with etanercept, either 25 mg twice weekly or 50 mg once weekly, for a minimum of 14 months at baseline
• Subject is currently receiving oral, sc or intramuscular methotrexate once weekly, 7.5 mg/week to 25 mg/week and at a stable dose for a minimum of 4 months at baseline.

Exclusion criteria

• Subject has earlier had an attempt of discontinuing etanercept for reasons of remission or low disease activity state.
• Subject has received any disease-modifying anti-rheumatic drug, other than methotrexate, within one month before baseline.
• Subject has had a dose of prednisone (or equivalent) >7.5 mg/day or has received intra-articular, intravenous, intramuscular, or subcutaneous corticosteroid within one month of baseline.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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91 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

50mg once weekly + methotrexate

Treatment:

Drug: Etanercept

Drug: Etanercept

2

Active Comparator group

Description:

25mg once weekly + methotrexate

Treatment:

Drug: Etanercept

Drug: Etanercept

3

Placebo Comparator group

Description:

once weekly + methotrexate

Treatment:

Drug: Placebo