Phase 4
N=210
Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel)
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01313208 ↗Enrolled (actual)
210
Serious AEs
3.3%
Results posted
Jun 2014
Primary outcome: Primary: Percentage of Participants Achieving DAS28 Low Disease Activity at Week 12 — 21.2; 33.0 percentage of participants — p=0.055
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- etanercept (Drug); Placebo (Drug); DMARD Therapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving DAS28 Low Disease Activity at Week 12 |
21.2; 33.0 | 0.055 |
| SECONDARY Percentage of Participants Achieving DAS28 Remission at Week 12 |
11.5; 18.9 | — |
| SECONDARY Percentage of Participants Achieving DAS28 Low Disease Activity at All Other Timepoints |
2.9; 1.0; 10.1; 21.0; 15.4; 24.5 | — |
| SECONDARY Percentage of Participants Achieving DAS28 Remission at All Other Timepoints |
1.0; 0.0; 5.1; 8.6; 6.7; 11.3 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Each Timepoint |
14.9; 28.6; 19.2; 36.8; 23.1; 50.0 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Each Timepoint |
3.0; 5.7; 4.8; 13.2; 4.8; 19.8 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Each Timepoint |
0.0; 1.9; 0.0; 1.9; 0.0; 5.7 | — |
| SECONDARY Percentage of Participants With RAPID3 Remission or Low Severity at Each Time Point |
9.4; 9.1; 21.1; 30.3; 21.6; 39.8 | — |
| SECONDARY Percentage of Participants Achieving Count Remission at Each Time Point |
0.0; 0.0; 1.0; 0.0; 0.0; 2.8 | — |
| SECONDARY Percentage of Participants Achieving CDAI Remission at Each Time Point |
0.0; 0.0; 1.0; 1.9; 0.0; 0.9 | — |
| SECONDARY Percentage of Participants Achieving CDAI Low Disease Activity at Each Time Point |
0.0; 0.0; 9.1; 12.3; 16.3; 18.9 | — |
| SECONDARY Clinical Disease Activity Index (CDAI) Score at Each Time Point |
30.18; 29.79; 26.67; 24.32; 24.81; 21.56 | — |
| SECONDARY Percentage of Participants Achieving SDAI Remission at Each Time Point |
0.0; 0.0; 1.0; 1.0; 1.0; 0.9 | — |
| SECONDARY Percentage of Participants Achieving SDAI Low Disease Activity at Each Time Point |
0.0; 0.0; 8.2; 12.4; 13.5; 18.9 | — |
| SECONDARY Simplified Clinical Disease Activity Index (SDAI) Score at Each Time Point |
31.00; 30.56; 27.83; 24.77; 25.81; 22.00 | — |
| SECONDARY Tender 28-Joint Count (TJC28) at Each Time Point |
11.1; 10.6; 10.1; 9.6; 9.4; 8.4 | — |
| SECONDARY Swollen 28-Joint Count (SJC28) at Each Time Point |
8.5; 8.4; 6.9; 6.7; 6.7; 5.4 | — |
| SECONDARY Patient Global Assessment of Joint Pain at Each Time Point |
43.74; 47.13; 40.98; 33.41; 38.65; 35.75 | — |
| SECONDARY Patient's Global Assessment of Disease Activity at Each Time Point |
5.0; 5.3; 4.7; 4.0; 4.5; 4.1 | — |
| SECONDARY Physician Global Assessment of Disease Activity at Each Time Point |
5.3; 5.4; 4.6; 4.0; 4.2; 3.7 | — |
| SECONDARY Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Each Time Point |
-0.093; -0.266; -0.164; -0.315; -0.208; -0.370 | — |
| SECONDARY C-reactive Protein Levels at Each Time Point |
9.44; 7.56; 8.68; 3.97; 9.75; 4.60 | — |
| SECONDARY Short Form 36 Health Survey (SF-36) Physical Functioning Domain Score at Each Time Point |
45.16; 45.71; 47.54; 51.86; 53.02; 52.06 | — |
| SECONDARY Short Form 36 Health Survey (SF-36) Vitality Domain Score at Each Time Point |
42.65; 41.11; 46.45; 49.27; 47.55; 48.90 | — |
| SECONDARY Short Form 36 Health Survey (SF-36) Role-Physical Domain Score at Each Time Point |
49.34; 51.69; 56.09; 58.09; 57.74; 57.83 | — |
| SECONDARY Short Form 36 Health Survey (SF-36) Bodily Pain Domain Score at Each Time Point |
41.98; 38.39; 47.77; 52.17; 51.15; 52.79 | — |
| SECONDARY Short Form 36 Health Survey (SF-36) General Health Perceptions Domain Score at Each Time Point |
49.13; 51.77; 52.52; 56.31; 52.21; 54.77 | — |
| SECONDARY Short Form 36 Health Survey (SF-36) Social Functioning Domain Score at Each Time Point |
65.14; 63.21; 69.04; 72.03; 69.68; 69.32 | — |
| SECONDARY Short Form 36 Health Survey (SF-36) Role-Emotional Domain Score at Each Time Point |
69.23; 66.36; 71.92; 72.56; 75.86; 71.87 | — |
| SECONDARY Short Form 36 Health Survey (SF-36) Mental Health Domain Score at Each Time Point |
70.14; 66.56; 69.74; 72.01; 72.05; 72.56 | — |
| SECONDARY Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Work Time Missed (Absenteeism) at Each Time Point |
3.54; 5.88; 4.18; 4.50; 8.07; 4.46 | — |
| SECONDARY Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Impairment While Working (Presenteeism) at Each Time Point |
34.39; 36.86; 31.91; 25.04; 25.49; 24.61 | — |
| SECONDARY Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Activity Impairment at Each Time Point |
49.29; 50.38; 41.22; 38.67; 39.16; 35.98 | — |
| SECONDARY Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Overall Work Impairment at Each Time Point |
34.79; 36.71; 33.14; 26.14; 27.23; 26.22 | — |
| SECONDARY Participant Assessment of Fatigue at Each Time Point |
49.38; 50.05; 50.31; 38.68; 46.48; 40.04 | — |
| SECONDARY Medical Outcomes Study (MOS) Sleep Disturbance Scale at Each Time Point |
45.02; 44.95; 46.42; 46.38; 46.10; 46.91 | — |
| SECONDARY Medical Outcomes Study (MOS) Sleep Shortness of Breath or Headache Scale at Each Time Point |
51.63; 49.25; 51.38; 50.20; 50.34; 49.77 | — |
| SECONDARY Medical Outcomes Study (MOS) Sleep Snoring Scale at Each Time Point |
47.78; 47.13; 49.14; 47.91; 49.47; 49.04 | — |
| SECONDARY Medical Outcomes Study (MOS) Sleep Adequacy Scale at Each Time Point |
47.12; 46.72; 47.63; 47.42; 46.86; 47.73 | — |
| SECONDARY Medical Outcomes Study (MOS) Sleep Daytime Somnolence Scale at Each Time Point |
46.82; 46.27; 46.62; 48.72; 47.80; 48.05 | — |
| SECONDARY Medical Outcomes Study (MOS) Sleep Problems Index I at Each Time Point |
46.16; 45.53; 46.91; 46.63; 46.82; 47.17 | — |
| SECONDARY Medical Outcomes Study (MOS) Sleep Problems Index II at Each Time Point |
45.69; 45.16; 46.63; 48.84; 46.51; 47.06 | — |
Summary
This study is designed to evaluate the effectiveness of adding etanercept to disease modifying anti-rheumatic drug (DMARD) therapy in patients with moderately active Rheumatoid Arthritis (RA).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01313208). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.