N/A
Completed N=309
A Retrospective Chart Review on the Use of Biologics in Monotherapy for the Treatment of Patients With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01640548 ↗Enrolled (actual)
309
Serious AEs
4.2%
Results posted
Oct 2015
Primary outcomePrimary: Percentage (%) of Participants Receiving Biologic Disease Modifying Anti-Rheumatic Drugs (bDMARDs) in Monotherapy as Current Treatment for RA According to National Institute for Health and Clinical Excellence (NICE) Guidelines by Type of bDMARD — 39.5; 28.8; 12.3; 10.7 percentage of participants
Summary
This non-interventional, retrospective, cross sectional chart review study will evaluate the management of rheumatoid arthritis patients with a biologic in monotherapy. Data from eligible patients will be collected from the patient's last visit on the prior rheumatoid arthritis treatment and from the most recent visit for the biological monotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage (%) of Participants Receiving Biologic Disease Modifying Anti-Rheumatic Drugs (bDMARDs) in Monotherapy as Current Treatment for RA According to National Institute for Health and Clinical Excellence (NICE) Guidelines by Type of bDMARD |
39.5; 28.8; 12.3; 10.7; 6.1; 1.0 | — |
| PRIMARY Percentage of Participants Treated With Traditional DMARDs as Their Previous Treatment for RA by Type of DMARD |
94.7; 78.9; 46.9; 42.9; 29.4; 9.9 | — |
| PRIMARY Percentage of Participants With bDMARD and Concomitant Traditional DMARD Regimen as Previous RA Treatment at Anytime Prior to Switch to bDMARD Monotherapy by Type of bDMARD |
51.9; 45.0; 16.8; 15.3; 9.2; 1.5 | — |
| PRIMARY Percentage of Participants With bDMARD Monotherapy as Previous RA Treatment at Anytime Prior to Switch to bDMARD Monotherapy |
53.0; 41.9; 13.7; 11.1; 6.0 | — |
| PRIMARY Percentage of Participants With Concomitant Treatment Other Than DMARDs for RA by Type of Treatment |
96.1; 83.8; 77.3 | — |
| PRIMARY Percentage of Participants by Reason for Choosing Previous and Current bDMARDs in Monotherapy |
84.1; 5.8; 4.9; 8.4 | — |
| SECONDARY Assessment of Disease Activity Score of 28 Joint Count (DAS28) by Either Erythrocyte Sedimentation Ratio (ESR) or C-Reactive Protein (CRP) |
3.41; 3.21 | — |
| SECONDARY Total Number of Tender Joints and Swollen Joints and Non-Evaluable DAS 28 Joints When Assessed Using Both ESR and CRP Methods |
3.2; 1.6; 0.4; 3.7; 2.3; 0.5 | — |
| SECONDARY Duration of Treatment With the Current bDMARD Usage in Monotherapy |
38.70; 41.70; 13.20; 36.20; 6.60; 13.60 | — |
| SECONDARY Duration of Treatment With bDMARDs in Monotherapy as Previous Treatment for RA |
8.55; 0.90; 10.50; 4.25; 7.80 | — |
| SECONDARY Duration of Treatment of bDMARD Administered With Concomitant Traditional DMARD as Previous Treatment for RA |
4.10; 18.60; 9.50; 15.95; 10.00; 0.00 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Diagnosis of rheumatoid arthritis by a Rheumatologist
- Patient being prescribed with a biologic in monotherapy
Exclusion Criteria
- N/A
Data sourced from ClinicalTrials.gov (NCT01640548). 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.