Phase 4
Completed N=91
Study Comparing The Effect On Disease Activity When Reducing Or Discontinuing Etanercept In Subjects With RA
Source: ClinicalTrials.gov NCT00858780 ↗Enrolled (actual)
91
Serious AEs
1.5%
Results posted
Aug 2013
Primary outcomePrimary: Percentage of Participant Who Were Non-Failures — 52.2; 44.4; 13.0 percentage of participants — p=0.007
Summary
This study involves Rheumatoid Arthritis patients in regular clinical setting who are already on etanercept treatment and are in remission or in a low disease activity (LDA) state, and is intended to identify parameters that can serve as guidance in clinical settings. This study will consider the clinical and radiographic course in subjects when etanercept treatment is tapered or discontinued, and analyze the subjects' experience of disease worsening and the predictive values of clinical parameters, serum biomarkers and imaging on the clinical and radiographic course in different treatment groups. The effect of re-treatment with etanercept at treatment failure will also be studied.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participant Who Were Non-Failures |
52.2; 44.4; 13.0 | 0.007 sig |
| SECONDARY Time to Treatment Failure (TTF) |
48.0; 36.1; 6.1 | — |
| SECONDARY Percentage of Participants With Remission or Low Disease Activity (LDA) |
100; 100; 100; 100; 100; 100 | — |
| SECONDARY Percentage of Visits During Which Participants Were in Remission or Low Disease Activity State |
82.7; 74.8; 55.3 | — |
| SECONDARY Disease Activity Score Based on 28-Joint Count (DAS28) at Randomization |
1.86; 1.93; 1.93 | — |
| SECONDARY Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48 |
0.11; 0.47; 0.85; 0.38; 0.32; 1.33 | — |
| SECONDARY Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 |
0.0; 0.0; 0.0; 0.0; 0.0; 1.0 | — |
| SECONDARY Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 |
4.00; 3.00; 2.25; 1.50; 0.25; 4.00 | — |
| SECONDARY Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 |
8.00; 12.00; 13.00; 2.50; 0.25; 10.00 | — |
| SECONDARY Participant General Health Visual Analog Scale (VAS) at Randomization |
14.43; 15.11; 18.52 | — |
| SECONDARY Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 |
8.21; 8.67; 8.37; 4.09; 10.21; 18.47 | — |
| SECONDARY Participant Pain Visual Analog Scale (VAS) at Randomization |
15.59; 12.96; 13.37 | — |
| SECONDARY Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 |
1.90; 5.67; 22.70; -3.05; 8.05; 34.27 | — |
| SECONDARY Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48 |
10.0; 0.5; 5.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48 |
10.00; 8.00; 8.00; 0.00; 0.00; 2.00 | — |
| SECONDARY Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48 |
2.00; 3.00; 1.60; 0.00; 0.00; 0.33 | — |
| SECONDARY Change From Randomization in Modified Total Sharp Score (mTSS) at Week 48 |
19.50; 54.25; 23.00; 0.00; 0.00; -1.00 | — |
| SECONDARY Magnetic Resonance Imaging (MRI) Findings at Randomization |
4.19; 4.90; 4.37; 1.50; 3.14; 3.63 | — |
| SECONDARY Change From Randomization in Magnetic Resonance Imaging (MRI) Findings (S-Score) at Week 12 |
-0.16; 1.36; -0.29 | — |
| SECONDARY Change From Randomization in Magnetic Resonance Imaging (MRI) Findings (O-Score, E-Score) at Week 12 |
0.00; 0.00; -3.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization |
44.4; 57.1; 84.2; 60.0; 50.0; 100 | — |
Eligibility Criteria
Inclusion criteria
- Subject has a current DAS28 equal to or less than 3.2.
- Subject is currently receiving treatment with etanercept, either 25 mg twice weekly or 50 mg once weekly, for a minimum of 14 months at baseline
- Subject is currently receiving oral, sc or intramuscular methotrexate once weekly, 7.5 mg/week to 25 mg/week and at a stable dose for a minimum of 4 months at baseline.
Exclusion Criteria
- Subject has earlier had an attempt of discontinuing etanercept for reasons of remission or low disease activity state.
- Subject has received any disease-modifying anti-rheumatic drug, other than methotrexate, within one month before baseline.
- Subject has had a dose of prednisone (or equivalent) >7.5 mg/day or has received intra-articular, intravenous, intramuscular, or subcutaneous corticosteroid within one month of baseline.
Data sourced from ClinicalTrials.gov (NCT00858780). 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.