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

Pfizer logo

Pfizer

Status and phase

Completed
Phase 4

Conditions

Rheumatoid Arthritis

Treatments

Drug: Placebo
Drug: Etanercept

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

91 participants in 3 patient groups, including a placebo group

1
Active Comparator group
Description:
50mg once weekly + methotrexate
Treatment:
Drug: Etanercept
2
Active Comparator group
Description:
25mg once weekly + methotrexate
Treatment:
Drug: Etanercept
3
Placebo Comparator group
Description:
once weekly + methotrexate
Treatment:
Drug: Placebo

Trial contacts and locations

16

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Data sourced from clinicaltrials.gov

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