Study of Etanercept Monotherapy vs Methotrexate Monotherapy for Maintenance of Rheumatoid Arthritis Remission



Status:Active, not recruiting
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:10/27/2018
Start Date:February 20, 2015
End Date:November 12, 2019

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A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis

The purpose of this study is to evaluate the efficacy of etanercept monotherapy compared to
methotrexate monotherapy on maintenance of remission in subjects with Rheumatoid Arthritis
who were on etanercept plus methotrexate therapy.

This is a multicenter, randomized withdrawal, double-blind controlled study in subjects with
Rheumatoid Arthritis on etanercept plus methotrexate therapy who are in very good disease
control for 6 months prior to study entry. The study will consist of a 30-day screening
period, a 24-week open label run-in period, a 48-week double-blind treatment period and a
30-day safety follow-up period.

Approximately 358 subjects will be enrolled and approximately 250 subjects will be randomly
assigned in a 2:2:1 ratio to one of three treatment groups: etanercept 50 mg weekly by
subcutaneous injection plus oral placebo for methotrexate (n = 100), oral methotrexate 10 to
25 mg weekly plus placebo for etanercept (n = 100) and etanercept 50 mg weekly by
subcutaneous injection plus oral methotrexate 10 to 25 mg weekly (n = 50).


Inclusion Criteria:

- Subjects must be adults with a history of moderate to severe Rheumatoid Arthritis;

- Subjects must be in very good Rheumatoid Arthritis disease control for ≥ 6 months and
be in remission as defined by a Simplified Disease Activity Index ≤ 3.3 at screening
and at the end of the run-in period.

- Subjects must be on etanercept 50 mg per week plus methotrexate therapy for ≥ 6 months
prior to the start of the run-in period. The methotrexate dose must be 10 to 25 mg per
week for ≥ 6 months prior to the start of the run-in period and the dose must be
stable for ≥ 8 weeks prior to the start of the run-in period.

- Subject has no known history of active tuberculosis, and has a negative test for
tuberculosis during screening.

Exclusion Criteria:- Subject has used biologic disease modifying antirheumatic drug other
than etanercept OR has used an oral janus kinase inhibitor ≤ 6 months prior to run-in visit
1

- Subject has any active infection (including chronic or localized infections) for which
anti-infectives were indicated within 4 weeks prior to run-in visit 1.

- Subject has known alcohol addiction or dependency or uses alcohol daily.

- Subject has one or more significant concurrent medical conditions per investigator
judgment, including the following:

- poorly controlled diabetes

- chronic kidney disease stage IIIb, IV, or V

- symptomatic heart failure (New York Heart Association class II, III, or IV)

- myocardial infarction or unstable angina pectoris within the past 12 months prior
to randomization

- uncontrolled hypertension

- severe chronic pulmonary disease (eg, requiring oxygen therapy)

- multiple sclerosis or any other demyelinating disease

- major chronic inflammatory disease or connective tissue disease other than
Rheumatoid Arthritis (eg, systemic lupus erythematosus with the exception of
secondary Sjögren's syndrome)
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