Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel)

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01313208
• Date of registration: 10/03/2011
• Prospective Registration: No
• Primary sponsor: Amgen
• Public title: Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel)
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Etanercept in Subjects With Moderately Active Rheumatoid Arthritis Despite DMARD Therapy
• Date of first enrolment: March 2011
• Target sample size: 210
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01313208
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Canada, United States

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female =18 and =80 years of age at time of screening

- Diagnosed with rheumatoid arthritis as determined by meeting 1987 American College of
Rheumatology (ACR) classification criteria and has had rheumatoid arthritis for at
least 6 months

- Moderate rheumatoid arthritis during screening, as defined by a disease activity score
(28 joint) calculated using the C-reactive protein formula (DAS28-CRP) > 3.2 and = 5.1

- Active rheumatoid arthritis defined as = 3 swollen joints (out of 28 joints examined)
and = 3 tender/painful joints (out of 28 joints examined) at screening and baseline.
(A full 66/68 count joint count will be performed at baseline, but only joints in the
28-count joint count will be considered for eligibility. The 28-joint count consists
of the finger joints excluding the distal interphalangeal joints, the wrists, elbows,
shoulders, and knees)

- Must be currently taking a DMARD such as methotrexate, sulfasalazine, leflunomide,
minocycline, and/or hydroxychloroquine

Exclusion Criteria:

- Prosthetic joint infection within 5 years of screening or native joint infection
within 1 year of screening

- Class IV rheumatoid arthritis according to ACR revised response criteria

- Any active infection (including chronic or localized infections) for which
anti-infectives were indicated within 28 days prior to first investigational product
dose

- Previously used more than one experimental biologic DMARD. Patient with prior use of
no more than one experimental biologic is permitted if the subject received no more
than 8 weeks of treatment. The use of the experimental biologic must not have occurred
within 2 months of the first dose of investigational product

- Previously used more than one commercially available biologic DMARD. Subject with
prior use of no more than one commercially available biologic is permitted if the
patient received no more than 8 weeks of treatment and did not discontinue because of
lack of effect. The use of the biologic must not have occurred within 2 months of the
first dose of investigational product. Acceptable prior use of biologics include the
following examples:

- No more than 4 injections of adalimumab

- No more than 8 (50 mg) injections of etanercept

- No more than 2 infusions of infliximab

- No more than 2 infusions of abatacept

- Additional inclusion (exclusion) criteria may apply



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: etanercept

Drug: DMARD Therapy

Drug: Placebo

Primary Outcome(s)

Percentage of Participants Achieving DAS28 Low Disease Activity at Week 12 [Time Frame: Week 12]

Secondary Outcome(s)

C-reactive Protein Levels at Each Time Point [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24]

Medical Outcomes Study (MOS) Sleep Adequacy Scale at Each Time Point [Time Frame: Baseline and Weeks 4, 12 and 24]

Medical Outcomes Study (MOS) Sleep Daytime Somnolence Scale at Each Time Point [Time Frame: Baseline and Weeks 4, 12 and 24]

Participant Assessment of Fatigue at Each Time Point [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24]

Medical Outcomes Study (MOS) Sleep Shortness of Breath or Headache Scale at Each Time Point [Time Frame: Baseline and Weeks 4, 12 and 24]

Percentage of Participants Achieving CDAI Low Disease Activity at Each Time Point [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24]

Percentage of Participants Achieving DAS28 Remission at All Other Timepoints [Time Frame: Baseline and Weeks 2, 4, 8, 16, 20 and 24]

Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Each Timepoint [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24]

Tender 28-Joint Count (TJC28) at Each Time Point [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24]

Medical Outcomes Study (MOS) Sleep Disturbance Scale at Each Time Point [Time Frame: Baseline and Weeks 4, 12 and 24]

Medical Outcomes Study (MOS) Sleep Snoring Scale at Each Time Point [Time Frame: Baseline and Weeks 4, 12 and 24]

Percentage of Participants Achieving CDAI Remission at Each Time Point [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24]

Percentage of Participants Achieving DAS28 Low Disease Activity at All Other Timepoints [Time Frame: Baseline and Weeks 2, 4, 8, 16, 20 and 24]

Short Form 36 Health Survey (SF-36) Physical Functioning Domain Score at Each Time Point [Time Frame: Baseline and Weeks 4, 12 and 24]

Short Form 36 Health Survey (SF-36) Social Functioning Domain Score at Each Time Point [Time Frame: Baseline and Weeks 4, 12 and 24]

Short Form 36 Health Survey (SF-36) Vitality Domain Score at Each Time Point [Time Frame: Baseline and Weeks 4, 12 and 24]

Simplified Clinical Disease Activity Index (SDAI) Score at Each Time Point [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24]

Percentage of Participants Achieving Count Remission at Each Time Point [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24]

Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Each Timepoint [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24]

Short Form 36 Health Survey (SF-36) Role-Physical Domain Score at Each Time Point [Time Frame: Baseline and Weeks 4, 12 and 24]

Medical Outcomes Study (MOS) Sleep Problems Index II at Each Time Point [Time Frame: Baseline and Weeks 4, 12 and 24]

Percentage of Participants Achieving SDAI Low Disease Activity at Each Time Point [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24]

Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Each Timepoint [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24]

Clinical Disease Activity Index (CDAI) Score at Each Time Point [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24]

Percentage of Participants Achieving SDAI Remission at Each Time Point [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24]

Short Form 36 Health Survey (SF-36) Mental Health Domain Score at Each Time Point [Time Frame: Baseline and Weeks 4, 12 and 24]

Short Form 36 Health Survey (SF-36) Role-Emotional Domain Score at Each Time Point [Time Frame: Baseline and Weeks 4, 12 and 24]

Swollen 28-Joint Count (SJC28) at Each Time Point [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24]

Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Impairment While Working (Presenteeism) at Each Time Point [Time Frame: Baseline and Weeks 4, 12 and 24]

Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Overall Work Impairment at Each Time Point [Time Frame: Baseline and Weeks 4, 12 and 24]

Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Each Time Point [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24]

Medical Outcomes Study (MOS) Sleep Problems Index I at Each Time Point [Time Frame: Baseline and Weeks 4, 12 and 24]

Patient Global Assessment of Joint Pain at Each Time Point [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24]

Patient's Global Assessment of Disease Activity at Each Time Point [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24]

Percentage of Participants Achieving DAS28 Remission at Week 12 [Time Frame: Week 12]

Percentage of Participants With RAPID3 Remission or Low Severity at Each Time Point [Time Frame: Baseline and Weeks 4, 12, and 24]

Physician Global Assessment of Disease Activity at Each Time Point [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24]

Short Form 36 Health Survey (SF-36) Bodily Pain Domain Score at Each Time Point [Time Frame: Baseline and Weeks 4, 12 and 24]

Short Form 36 Health Survey (SF-36) General Health Perceptions Domain Score at Each Time Point [Time Frame: Baseline and Weeks 4, 12 and 24]

Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Activity Impairment at Each Time Point [Time Frame: Baseline and Weeks 4, 12 and 24]

Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Work Time Missed (Absenteeism) at Each Time Point [Time Frame: Baseline and Weeks 4, 12 and 24]

Secondary ID(s)

20070561

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 17/06/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01313208