Phase 4
Completed N=834
Study Comparing Etanercept in Combination With Methotrexate in Subjects With Rheumatoid Arthritis
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT00565409 ↗
Enrolled (actual)
834
Serious AEs
5.1%
Results posted
Aug 2015
Primary outcomePrimary: Percentage of Participants Achieving 28 Joint Disease Activity Score (DAS28) Less Than or Equal to (≤) 3.2 at Week 88 — 82.6; 79.1; 42.6 percentage of participants — p=<0.0001
Summary
To compare the efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with that of methotrexate monotherapy in the treatment of rheumatoid arthritis over 88 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving 28 Joint Disease Activity Score (DAS28) Less Than or Equal to (≤) 3.2 at Week 88 |
82.6; 79.1; 42.6 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving DAS28 Low Disease Activity or Remission at Baseline, Weeks 4, 8, 12, 20, 28 and 36 |
0.36; 35.98; 49.57; 61.75; 69.25; 75.79 | — |
| SECONDARY Percentage of Participants Achieving DAS28 Low Disease Activity or Remission |
98.5; 99.0; 100.0; 87.8; 84.3; 65.4 | 0.0853 |
| SECONDARY Change From Baseline in DAS28 at Weeks 4, 8, 12, 20, 28 and 36 |
4.37; -0.88; -1.22; -1.45; -1.60; -1.72 | — |
| SECONDARY Change From Week 36 in DAS28 at Weeks 40, 48, 56, 64, 72, 80 and 88 |
0.30; 0.31; 0.84; 0.40; 0.36; 1.25 | <0.0001 sig |
| SECONDARY Time to Loss of Low Disease Activity DAS28 and a Change of ≥ 0.6 Units in the DAS28 |
NA; NA; 85.0 | <0.0001 sig |
| SECONDARY Time to Loss of Low Disease Activity DAS28 |
366.0; NA; 85.0 | <0.0001 sig |
| SECONDARY Proportion of Time Participants Had Low Disease Activity DAS28 Week 36 to Week 88 |
0.85; 0.84; 0.58 | — |
| SECONDARY Change From Baseline in Prorated Swollen Joint Count at Weeks 4, 8, 12, 20, 28 and 36 |
3.82; -1.31; -1.96; -2.29; -2.60; -2.70 | — |
| SECONDARY Prorated Swollen Joint Count at Week 36 |
0.63; 0.57; 0.59 | — |
| SECONDARY Change From Week 36 in Prorated Swollen Joint Count at Weeks 40, 48, 56, 64, 72, 80 and 88 |
0.10; 0.14; 0.91; 0.25; 0.21; 1.38 | <0.0001 sig |
| SECONDARY Change From Baseline in the Painful Joint Count at Weeks 4, 8, 12, 20, 28 and 36 |
5.09; -1.68; -2.50; -2.86; -3.11; -3.32 | — |
| SECONDARY Painful Joint Count at Week 36 |
0.64; 0.69; 0.74 | — |
| SECONDARY Change From Week 36 in Painful Joint Count at Weeks 40, 48, 56, 64, 72, 80 and 88 |
0.61; 0.49; 1.47; 0.67; 0.63; 2.69 | 0.0003 sig |
| SECONDARY Change From Baseline in the Physician Global Assessment (PGA) at Weeks 4, 8, 12, 20, 28 and 36 |
4.11; -1.29; -1.84; -2.09; -2.26; -2.45 | — |
| SECONDARY PGA Score at Week 36 |
1.06; 1.19; 1.11 | — |
| SECONDARY Change From Week 36 in the PGA Score at Weeks 40, 48, 56, 64, 72, 80 and 88 |
0.25; 0.24; 0.98; 0.37; 0.26; 1.48 | <0.0001 sig |
| SECONDARY Change From Baseline in Patient's Global Assessment (PtGA) of Arthritis Pain at Weeks 4, 8, 12, 20, 28 and 36 |
4.85; -1.16; -1.46; -1.68; -2.01; -2.14 | — |
| SECONDARY PtGA of Arthritis Pain at Week 36 |
1.80; 1.77; 1.86 | — |
| SECONDARY Change From Week 36 in PtGA of Arthritis Pain at Weeks 40, 48, 56, 64, 72, 80, 88 |
0.41; 0.46; 1.28; 0.36; 0.54; 1.76 | <0.0001 sig |
| SECONDARY Change From Baseline in Duration of Morning Stiffness at Weeks 4, 8, 12, 20, 28 and 36 |
176.98; -81.31; -80.73; -90.64; -101.75; -97.85 | — |
| SECONDARY Duration of Morning Stiffness at Week 36 |
34.60; 36.46; 38.03 | — |
| SECONDARY Change From Week 36 in Duration of Morning Stiffness at Weeks 40, 48, 56, 64, 72, 80, 88 |
3.43; 14.00; 45.10; -7.64; 35.54; 72.41 | 0.0214 sig |
| SECONDARY Change From Baseline in General Health at Weeks 4, 8, 12, 20, 28 and 36 |
43.37; -9.39; -12.36; -15.69; -18.65; -19.47 | — |
| SECONDARY General Health at Week 36 |
14.12; 14.77; 15.09 | — |
| SECONDARY Change From Week 36 in General Health at Weeks 40, 48, 56, 64, 72, 80, 88 |
3.26; 5.82; 12.05; 4.67; 5.36; 16.76 | <0.0001 sig |
| SECONDARY Change From Baseline in Pain at Weeks 4, 8, 12, 20, 28 and 36 |
45.47; -13.06; -17.11; -19.47; -22.11; -22.98 | — |
| SECONDARY Pain at Week 36 |
12.78; 13.87; 14.21 | — |
| SECONDARY Change From Week 36 in Pain at Weeks 40, 48, 56, 64, 72, 80 and 88 |
4.50; 4.91; 13.05; 5.16; 5.66; 18.77 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving an Acceptable State on the Patient Acceptable Symptom State (PASS) at Baseline and Week 36 |
44.90; 86.80 | 0.0001 sig |
| SECONDARY Percentage of Participants Achieving an Acceptable State on the PASS at Week 36 and Weeks 64 and 88 |
93.5; 89.9; 93.9; 90.0; 88.7; 65.8 | 0.8974 |
| SECONDARY Percentage of Participants Achieving European League Against Rheumatism (EULAR) Good or Moderate Response at Weeks 4, 8, 12, 20, 28 and 36 |
61.95; 75.37; 82.03; 86.63; 87.24; 87.97 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving EULAR Good or Moderate Response at Week 36, 40, 48, 56, 64, 72, 80 and 88 |
99.0; 99.0; 97.5; 93.8; 95.4; 76.1 | 0.1718 |
| SECONDARY Percentage of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response at Weeks 4, 8, 12, 20, 28 and 36 |
38.62; 53.14; 61.29; 66.87; 70.75; 72.82 | <0.0001 sig |
| SECONDARY Percentage of Participants With an ACR20 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88 |
86.5; 85.1; 88.3; 76.9; 77.7; 61.2 | 0.6006 |
| SECONDARY Percentage of Participants With an ACR50 Response at Weeks 4, 8, 12, 20, 28 and 36 |
11.25; 22.88; 31.99; 41.99; 51.33; 59.83 | <0.0001 sig |
| SECONDARY Percentage of Participants With an ACR50 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88 |
76.5; 70.6; 74.1; 60.5; 57.9; 41.0 | 0.5263 |
| SECONDARY Percentage of Participants With an ACR70 Response at Weeks 4, 8, 12, 20, 28 and 36 |
2.81; 6.77; 10.26; 16.75; 22.45; 27.79 | <0.0001 sig |
| SECONDARY Percentage of Participants With an ACR70 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88 |
42.0; 33.3; 33.0; 28.7; 27.9; 17.6 | 0.0575 |
| SECONDARY Percentage of Participants With an ACR90 Response at Weeks 4, 8, 12, 20, 28 and 36 |
1.02; 1.23; 1.83; 4.13; 6.31; 8.25 | <0.0001 sig |
| SECONDARY Percentage of Participants With an ACR90 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88 |
13.5; 14.4; 5.6; 10.3; 9.1; 4.8 | 0.0089 sig |
| SECONDARY DAS28 at Week 36 |
1.99; 2.06; 2.07 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of rheumatoid arthritis.
- Currently receiving an optimal dose of oral Methotrexate (MTX)(at least 15 mg/week but no more than 25 mg/week) for the treatment of rheumatoid arthritis.
- Active rheumatoid arthritis at the time of screening.
Exclusion Criteria
- Previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF) inhibitors, or other biologic agents.
- Concurrent treatment with any disease-modifying anti-rheumatoid drugs (DMARD), other than MTX within 28 days before baseline.
- Concurrent treatment with more than 1 non-steroid anti-inflammatory drug (NSAID) at baseline.
Data sourced from ClinicalTrials.gov (NCT00565409). 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. Informational only — not medical advice.