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

• Register: ClinicalTrials.gov
• Last refreshed on: 23 January 2023
• Main ID: NCT02373813
• Date of registration: 12/01/2015
• Prospective Registration: Yes
• Primary sponsor: Amgen
• Public title: Study of Etanercept Monotherapy vs Methotrexate Monotherapy for Maintenance of Rheumatoid Arthritis Remission
• Scientific title: A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis
• Date of first enrolment: February 20, 2015
• Target sample size: 371
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02373813
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Bulgaria, Canada, Czech Republic, Czechia, France, Germany, Greece, Hungary, Italy, Mexico, Poland, Portugal, South Africa, Spain, United States

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & exclusion criteria

Inclusion Criteria (Part 1, Run-In Period):

- 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 (Part 1, Run-In Period):

- 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)

Inclusion Criteria (Part 2, Treatment Period):

- 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).

Exclusion Criteria (Part 2, Treatment Period):

- 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.

NOTE: Other inclusion/exclusion criteria may apply per protocol.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: etanercept pre-filled syringe subcutaneous injection

Drug: Placebo for etanercept subcutaneous injection

Dietary Supplement: Folic acid (non-investigational product)

Drug: Oral methotrexate

Drug: Placebo for methotrexate

Primary Outcome(s)

Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission (= 3.3) at Week 48: Etanercept Monotherapy vs. Methotrexate Monotherapy [Time Frame: Week 48]

Secondary Outcome(s)

Disease Activity Score (28 Joint) Calculated Using the Erythrocyte Sedimentation Rate Formula (DAS28-ESR) at All Measured Timepoints [Time Frame: Baseline, Week 12, Week 24, Week 36 and Week 48]

Change From Baseline in DAS28-ESR at All Measured Timepoints [Time Frame: Baseline, Week 12, Week 24, Week 36 and Week 48]

Percentage of Participants With SDAI Remission (= 3.3) at All Measured Timepoints [Time Frame: Baseline, Week 12, Week 24, Week 36 and Week 48]

Change From Baseline in SDAI Score at All Measured Timepoints [Time Frame: Baseline, Week 12, Week 24, Week 36 and Week 48]

Percentage of Participants With Boolean Remission at All Measured Timepoints [Time Frame: Baseline, Week 12, Week 24, Week 36 and Week 48]

Time to Recapture SDAI Remission After Starting Rescue Treatment [Time Frame: Between rescue and remission or Week 48, whichever comes first.]

Change From Baseline in CDAI at All Measured Timepoints [Time Frame: Baseline, Week 12, Week 24, Week 36 and Week 48]

Percentage of Participants Receiving Rescue Treatment Who Experienced SDAI Remission at Week 48 [Time Frame: Week 48]

Percentage of Participants With SDAI Remission (= 3.3) at Week 48: Etanercept and Methotrexate vs. Methotrexate Monotherapy [Time Frame: Week 48]

Change From Baseline in DAS28-CRP at All Measured Timepoints [Time Frame: Baseline, Week 12, Week 24, Week 36 and Week 48]

Time to Disease Worsening [Time Frame: up to Week 48]

Clinical Disease Activity Index (CDAI) at All Measured Timepoints [Time Frame: Baseline, Week 12, Week 24, Week 36 and Week 48]

Disease Activity Score (28 Joint) Using the C-Reactive Protein Formula (DAS28-CRP) at All Measured Timepoints [Time Frame: Baseline, Week 12, Week 24, Week 36 and Week 48]

SDAI Score at All Measured Timepoints [Time Frame: Baseline, Week 12, Week 24, Week 36 and Week 48]

Percentage of Participants With Disease Worsening [Time Frame: Baseline, Week 12, Week 24, Week 36 and Week 48]

Secondary ID(s)

20110186

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/12/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02373813