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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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21 December 2021 |
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Main ID: |
EUCTR2007-006657-63-HU |
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Date of registration:
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15/02/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA) - DOSERA
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Scientific title:
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Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA) - DOSERA |
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Date of first enrolment:
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26/03/2010 |
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Target sample size:
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186 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-006657-63 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: Patients who fail during the trial will enter into an open-label phase
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Denmark
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Finland
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Hungary
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Iceland
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Sweden
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Key inclusion & exclusion criteria
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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)
1ยท 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.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis (RA) patients who are on Etanercept (ETN) treatment and are in remission or in a Low Disease Activity (LDA) state
MedDRA version: 9.1
Level: LLT
Classification code 10039073
Term: Rheumatoid arthritis
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Intervention(s)
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Trade Name: Enbrel 25 mg powder and solvent for solution for injection
Product Name: Enbrel
Pharmaceutical Form: Powder and solvent for solution for injection
Pharmaceutical form of the placebo: Powder and solvent for solution for injection
Route of administration of the placebo: Subcutaneous use
Trade Name: Enbrel 50 mg powder and solvent for solution for injection
Product Name: Enbrel
Pharmaceutical Form: Powder and solvent for solution for injection
Pharmaceutical form of the placebo: Powder and solvent for solution for injection
Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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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.
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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
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Secondary Objective: 1. To compare the effect on disease activity of the combination of ETN 25 mg QW plus MTX to
a. combination of ETN 50 mg QW plus MTX
b. 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.
2. To compare the change in modified Total Sharp Score (mTSS) over 48 weeks among the treatment groups.
3. To compare the change in MRI findings over 12 weeks among the treatment groups.
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Secondary ID(s)
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0881K1-4500-EU
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2007-006657-63-FI
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 18/03/2010
Contact:
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