Phase 4
Completed N=306
Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis
Active Rheumatoid Arthritis · Arthritis, Rheumatoid · Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00913458 ↗
Enrolled (actual)
306
Serious AEs
5.9%
Results posted
Jul 2014
Primary outcomePrimary: Number of Participants That Met Sustained Remission at Week 76 and Week 91 Based on DAS28 Score — 40; 26; 15 Participants — p=<0.0001
Summary
Study to evaluate whether there is sustained remission and productivity in subjects with early rheumatoid arthritis started on etanercept plus methotrexate treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Met Sustained Remission at Week 76 and Week 91 Based on DAS28 Score |
40; 26; 15 | <0.0001 sig |
| SECONDARY Number of Participants Achieving Complete Response (Using Disease Activity Score Based on 28-joint Count, Modified Total Sharp Score, Health Assessment Questionnaire) |
89 | <0.0001 sig |
| SECONDARY Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52 and Final on Therapy |
0.3; 0.4 | 0.1183 |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Overall Work Impairment Due to Problem |
-27.6; -32.2; -35.9; -37.3; -35.5 | <0.0001 sig |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Impairment While Working Due to Problem |
-27.1; -31.5; -35.3; -36.6; -33.7 | <0.0001 sig |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Work Time Missed Due to Problem |
-8.9; -8.8; -9.0; -12.9; -10.7 | 0.0063 sig |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Activity Impairment Due to Problem |
-30.3; -34.7; -39.9; -41.3; -36.4 | <0.0001 sig |
| SECONDARY Number of Participants Achieving American College of Rhematology 20% (ACR 20) Response |
139; 195; 225; 232; 232; 235 | <0.0001 sig |
| SECONDARY Number of Participants Achieving American College of Rhematology 50% (ACR 50) Response |
52; 114; 144; 169; 190; 218 | <0.0001 sig |
| SECONDARY Number of Participants Achieving American College of Rhematology 70% (ACR 70) Response |
17; 49; 80; 115; 146; 178 | <0.0001 sig |
| SECONDARY Number of Participants Achieving American College of Rhematology 90% (ACR 90) Response |
2; 11; 22; 34; 70; 85 | <0.0001 sig |
| SECONDARY Change From Baseline in Physician's Global Assessment of Disease Activity |
-21.1; -29.9; -34.8; -38.7; -42.4; -46.5 | <0.0001 sig |
| SECONDARY Change From Baseline in Participant's Global Assessment of Disease Activity |
-23.4; -27.4; -31.8; -34.6; -40.1; -44.8 | <0.0001 sig |
| SECONDARY Change From Baseline in DAS44 Score at All Visits |
-1.3; -1.9; -2.3; -2.5; -2.9; -3.2 | <0.0001 sig |
| SECONDARY Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44)-Remission |
13; 48; 81; 95; 142; 174 | <0.0001 sig |
| SECONDARY Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44) - Low Disease Activity |
63; 65; 65; 62; 60; 54 | 0.0548 |
| SECONDARY Proportion of Subjects Achieving a Patient Acceptable Symptom State (PASS) at Each Visit |
151; 180; 189; 197; 213; 219 | <0.0001 sig |
| SECONDARY Number of Participants With an American College of Rheumatology 20% (ACR20) Response |
61; 63; 64; 59; 59; 56 | 0.4075 |
| SECONDARY Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response |
58; 61; 62; 55; 58; 48 | 0.5951 |
| SECONDARY Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response |
52; 56; 52; 46; 51; 37 | 0.6152 |
| SECONDARY Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response |
32; 31; 25; 32; 31; 20 | 0.0535 |
| SECONDARY Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44) Remission |
60; 62; 60; 52; 52; 47 | 0.0788 |
| SECONDARY Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44) - Low Disease Activity |
63; 65; 65; 62; 60; 54 | 0.0548 |
| SECONDARY Number of Participants Achieving Complete Response (Using Disease Activity Score Based on a 28-joint Count, Modified Total Sharp Score, Health Assessment Questionnaire) |
36; 19; 7 | 0.0017 sig |
| SECONDARY Physician's Global Assessment of Disease Activity |
5.0; 4.2; 6.3; 5.5; 7.7; 12.2 | 0.0328 sig |
| SECONDARY Participant's Global Assessment of Disease Activity |
5.8; 5.7; 9.3; 10.3; 9.7; 17.3 | 0.2473 |
| SECONDARY Participant's Global Assessment of Pain (Visual Analogue Scale) (VAS) |
7.3; 6.9; 9.9; 10.9; 10.2; 18.8 | 0.1248 |
| SECONDARY Number of Participants Achieving Patient Acceptable Symptom State (PASS) |
57; 64; 61; 57; 58; 53 | 0.4717 |
| SECONDARY Modified Total Sharp Score (mTSS) at Week 52 |
8.4; 8.4; 8.6 | — |
| SECONDARY Change From Baseline mTSS at Week 91 and Final on Therapy |
0.0; 0.0; 0.5; 0.1; -0.0; 0.4 | 0.9652 |
| SECONDARY Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Work Time Missed in the Past 7 Days Due to Problem |
0.2; 0.1; 0.0 | — |
| SECONDARY Change From Baseline in WPAI Questionnaire: Percent Work Time Missed in the Past 7 Days Due to Problem |
1.9; 2.6; 6.1; -0.1; 2.9; 2.6 | 0.9338 |
| SECONDARY WPAI Questionnaire: Percent Impairment While Working in the Past 7 Days Due to Problem |
6.2; 8.9; 14.2 | — |
| SECONDARY Change From Baseline in WPAI Questionnaire: Percent Impairment While Working in the Past 7 Days Due to Problem |
-2.5; 9.6; 18.2; -0.6; 2.3; 12.2 | 0.1303 |
| SECONDARY WPAI Questionnaire: Percent Overall Work Impairment in the Past 7 Days Due to Problem |
5.3; 6.7; 9.2 | — |
| SECONDARY Change From Baseline in WPAI Questionnaire: Percent Overall Work Impairment in the Past 7 Days Due to Problem |
0.1; 11.5; 22.4; -0.9; 2.6; 16.6 | 0.4664 |
| SECONDARY WPAI Questionnaire: Percent Activity Impairment in the Past 7 Days Due to Problem |
8.6; 10.0; 16.8 | — |
| SECONDARY Change From Baseline in WPAI Questionnaire: Percent Activity Impairment in the Past 7 Days Due to Problem |
-0.5; 9.9; 19.1; 2.9; 7.1; 13.9 | 0.0256 sig |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of early rheumatoid arthritis.
- Methotrexate (MTX) naive.
- Active early rheumatoid arthritis at the time of enrollment.
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), within 4 weeks before baseline.
- Concurrent treatment with more than 1 non-steroidal anti-inflammatory drug (NSAID) at baseline.
Data sourced from ClinicalTrials.gov (NCT00913458). 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.