Resumen

The purpose of this study is to evaluate the efficacy of etanercept monotherapy compared to methotrexate monotherapy on maintenance of remission in participants with rheumatoid arthritis (RA) who were on etanercept plus methotrexate therapy. This is a multicenter, randomized withdrawal, double-blind controlled study in participants 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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.
SDAI ≤ 3.3 at run-in visit 3
Subject if female and not at least 2 years postmenopausal or history of hysterectomy, bilateral salpingectomy, or bilateral oophorectomy, has a negative urine pregnancy test at baseline (day 1).

Criterios de exclusión

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)
Any clinically significant change in the Part 1 eligibility criteria during the run-in period
SDAI \> 3.3 and ≤ 11 on two consecutive visits at least two weeks apart OR SDAI \> 3.3 and ≤ 11 on two or more separate visits OR SDAI \> 11 at any time during the run-in period
Subject has a clinically significant laboratory abnormality during run-in period which in the opinion of the investigator poses a safety risk, will prevent the subject from completing the study, or will interfere with the interpretation of the study results during the run-in period.

Intervenciones

drug

etanercept pre-filled syringe subcutaneous injection

etanercept for injection in pre-filled syringes

drug

Oral methotrexate

During the open-label run-in period, methotrexate will be provided as 2.5 mg tablets. During the double-blind treatment period, methotrexate will be provided as 2.5 mg capsules.

drug

Placebo for etanercept subcutaneous injection

etanercept placebo for injection in pre-filled syringes

drug

Placebo for methotrexate

methotrexate placebo capsules

dietary_supplement

Folic acid (non-investigational product)

Folic acid 5 to 7 mg per week as per investigator judgment or according to local standard of care.

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

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

etanercept pre-filled syringe subcutaneous injection

Oral methotrexate

Placebo for etanercept subcutaneous injection

Placebo for methotrexate

Folic acid (non-investigational product)

Ubicaciones

Research Site

Patrocinadores