N/A
Completed N=450
A Retrospective, Observational Chart Review of Biologics in Monotherapy Versus the Combination Biologic Plus Methotrexate in Patients With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01866150 ↗Enrolled (actual)
450
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcomePrimary: Percentage of Participants Who Achieved Disease Activity Score Based on 28-joint Count (DAS-28) and Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at 6 Months (DAS28<2.6) — 30.7; 31.9 percentage of participants — p=0.8222
Summary
This cross-sectional, non-interventional, retrospective chart review will compare the efficacy and safety of biologic monotherapy and biologic and methotrexate combination therapy in patients with rheumatoid arthritis who have had an inadequate response to prior treatment with disease-modifying anti-rheumatic drugs including methotrexate. Data will be collected from patients who have been on first-line biologic treatment for at least 6 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved Disease Activity Score Based on 28-joint Count (DAS-28) and Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at 6 Months (DAS28<2.6) |
30.7; 31.9 | 0.8222 |
| SECONDARY Percentage of Participants Who Achieved DAS28-ESR Remission (DAS28-ESR <2.6) at 3 Months and at the Last Visit After Initiation of First-Line Biologic Treatment |
23.9; 27.6; 44.4; 46.9 | 0.4727 |
| SECONDARY Percentage of Participants Who Achieved Low Disease Activity (LDA) (DAS28-ESR <3.2) at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment. |
42.5; 41.6; 50.0; 53.4; 57.1; 67.1 | 0.8769 |
| SECONDARY Change From Baseline in DAS28 at Months 3, 6 and at The Last Visit After Initiation of First-Line Biologic Treatment |
-2.74; -2.84; -3.00; -3.18; -3.39; -3.54 | 0.5195 |
| SECONDARY Percentage of Participants by Category of DAS28 Score and Timepoint |
2.6; 0.5; 0.9; 0.5; 96.6; 99.1 | — |
| SECONDARY Duration of Treatment |
57.30; 48.48 | 0.0237 sig |
| SECONDARY Average Methotrexate Dose of Participants on Biological Combination Treatment |
17.12 | — |
| SECONDARY Change From Baseline in Total Number of Tender Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment. |
17.1; 16.3; -12.5; -12.4; -14.4; -13.4 | — |
| SECONDARY Change From Baseline in Total Number of Swollen Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment |
9.1; 10.0; -7.0; -7.2; -7.7; -8.3 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Diagnosis of rheumatoid arthritis by a rheumatologist
- Patients who have responded inadequately to methotrexate or disease-modifying anti-rheumatic drugs (DMARDs) and are being prescribed a biologic in monotherapy or in combination with methotrexate and other classical DMARDs as per NICE guidelines
Exclusion Criteria
- Primary diagnosis of a condition other than rheumatoid arthritis
- Current treatment with a biologic in combination without methotrexate
- Prior treatment with an experimental agent for rheumatoid arthritis
Data sourced from ClinicalTrials.gov (NCT01866150). 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.