Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA) - DOSERA

Phase 1

• Conditions: Rheumatoid Arthritis (RA) patients who are on Etanercept (ETN) treatment and are in remission or in a Low Disease Activity (LDA) state; MedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis

• Registration Number: EUCTR2007-006657-63-HU
• Lead Sponsor: Wyeth Pharmaceuticals France

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-15
• Study Completion: 2012-06-20
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

Inclusion Criteria for the Open-label Period (Period 1):
Subject must meet all of the following conditions in order to be enrolled in the study:
1. Men and women have a diagnosis of RA based on the ACR Revised Criteria for RA.
2. Subject has a current DAS28 =3.2.
3. Subject is currently receiving treatment with sc ETN, either 25 mg BW or 50 mg QW, for a minimum of 14 months at baseline
4. Subject is currently receiving oral, sc or im MTX, 7.5 mg/week to 25 mg/week and at a stable dose for a minimum of 4 months at baseline.

Inclusion Criteria for the Double-Blind Randomized Period (Period 2)
1. Subject has completed open-label period 1 and has had DAS28 = 3.2 at all visits during period 1 and at randomization.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion Criteria for the Open-Label Period (Period 1)
1· Subject has earlier had an attempt of discontinuing ETN for reasons of remission or LDA state.
2. Subject has received any disease-modifying anti-rheumatic drug (DMARD), other than MTX, a dose of prednisone (or equivalent) >7.5 mg/day or has received ia, iv, im, or sc corticosteroid within one month before baseline.

Exclusion Criteria for the Double-Blind Randomized Period 2

1. Subject has used prohibited concomitant medication in period 1 or has not attended all visits in Period 1.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the effect on disease activity of the combination of ETN 50 mg QW plus methotrexate (MTX) to placebo plus MTX over 48 weeks in RA subjects who at study start are in remission or LDA state with combination therapy with ETN 50mg weekly plus MTX;Secondary Objective: 1. To compare the effect on disease activity of the combination of ETN 25 mg QW plus MTX to <br><br>a. combination of ETN 50 mg QW plus MTX <br>b. placebo plus MTX <br><br>over 48 weeks in RA subjects who at study start are in remission or LDA state with combination therapy with ETN 50mg weekly plus MTX. <br><br>2. To compare the change in modified Total Sharp Score (mTSS) over 48 weeks among the treatment groups. <br><br>3. To compare the change in MRI findings over 12 weeks among the treatment groups.;Primary end point(s): Proportion of subjects who are non-failures at Week 48. These subjects are still in Period 2 at study end, which means they have not fulfilled predefined failure criteria during the study.