A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-Weekly Administration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate

• Register: EUCTR
• Last refreshed on: 8 October 2021
• Main ID: EUCTR2007-000896-41-FR
• Date of registration: 29/02/2008
• Prospective Registration: Yes
• Primary sponsor: Wyeth Pharmaceuticals France
• Public title: A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-Weekly Administration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate
• Scientific title: A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-Weekly Administration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate
• Date of first enrolment: 07/05/2008
• Target sample size: 900
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-000896-41
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: Single blind: Double blind: yes; Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: yes; Placebo: yes; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Austria, Belgium, Czech Republic, France, Germany, Hungary, Italy, Netherlands, Spain, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subject has a diagnosis of RA based on the 1987 American College of Rheumatology (ACR) Revised Criteria for RA.
2. Subject is currently receiving an optimal dose of oral MTX once weekly for the treatment of RA, in the opinion of the investigator, but at least 15 mg/week but no more than 25 mg/week and at a stable dose for a minimum of 8 weeks at screening.
3. Subject has moderate RA disease activity, as defined by a DAS28 >3.2 and =5.1 at both the screening and baseline visits.
4. Subject has a functional status of class I, II, or III as defined by the ACR Revised Criteria.
5. Subject is 18 to 70 years of age at the time of consent.
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:
1. Subject has had previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF-a) inhibitors, or other biologic agents.
2. Subject has received any DMARD, other than MTX, within 28 days before baseline.
3. Subject has had concurrent treatment with more than 1 NSAID at baseline.
4. Subject has had a dose of an NSAID that has changed within 14 days before screening.
5. Subject has had a dose of prednisone >10 mg/day (or equivalent) or has had a dose changed within 14 days before screening.
6. Subject has received an intra-articular, intravenous, intramuscular, or subcutaneous (SC) corticosteroid within 28 days before screening.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Rheumatoid arthritis

Intervention(s)

Trade Name: Enbrel
Product Name: Etanercept
Product Code: 0881
Pharmaceutical Form: Injection*
INN or Proposed INN: ETANERCEPT
CAS Number: 185243690
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Subcutaneous use

Trade Name: Enbrel
Product Name: Etanercept
Product Code: 0881
Pharmaceutical Form: Injection*
INN or Proposed INN: ETANERCEPT
CAS Number: 185243690
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: ETANERCEPT
Concentration unit: mg milligram(s)
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Subcutaneous use

Trade Name: Methotrexate
Product Name: Methotrexate
Pharmaceutical Form: Tablet
INN or Proposed INN: METHOTREXATE
CAS Number: 59052
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Concentration unit: mg milligram(s)

Primary Outcome(s)

Primary end point(s): Proportion of subjects with DAS28 <3.2 at week 88 during period 2.

Main Objective: To compare the efficacy of the combination of etanercept 50 mg once weekly plus MTX with that of MTX monotherapy at week 88 in subjects with moderate RA who have achieved low disease activity or remission after 36-week treatment with open-label etanercept 50 mg once weekly plus MTX. The conditional primary objective will be to compare the efficacy of the combination of etanercept 25 mg once weekly plus MTX with that of MTX monotherapy at week 88 in subjects with moderate RA who have achieved low disease activity or remission after 36-week treatment with open-label etanercept 50 mg once weekly plus MTX.
The study hypothesis is that the combination of etanercept 50 mg once weekly plus MTX will be superior to MTX monotherapy, as determined by the proportion of subjects remaining in low disease activity or remission at week 88.
The conditional hypothesis is that the combination of etanercept 25 mg once weekly plus MTX will be superior to MTX monotherapy.

Secondary Objective: To compare the efficacy of etanercept 50 mg once weekly plus MTX with etanercept 25 mg once weekly plus MTX at week 88 in subjects with moderate RA who have achieved low disease activity or remission after 36-week treatment with open-label etanercept 50 mg once weekly plus MTX.

To assess the efficacy of etanercept 50 mg once weekly plus MTX over 36 weeks of the open-label period.

To assess the safety of the treatment regimens over 36 weeks during the open-label period and 52 weeks of the double-blind period.

Secondary ID(s)

2007-000896-41-HU

0881A1-4423

Ethics review

Status: Approved
Approval date: 07/05/2008
Contact:

Results

• Results available: Yes
• Date Posted: 13/02/2015
• Date Completed: 30/05/2011
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-000896-41/results