N/A
N=301
Study to Assess the Management of Synthetic Disease-modifying Antirheumatic Drug (DMARD) at the Onset of Adverse Events, Intolerance or Lack of Efficacy in Rheumatoid Arthritis (RA)
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT02094326 ↗Enrolled (actual)
301
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Percentage of Patients Who Present Adverse Events, Intolerance or Lack of Efficacy to Synthetic DMARDs That Causes a Change in Treatment Prescription When Used in Routine Clinical Practice — 65.1 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fundación Andaluza de Reumatología
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Who Present Adverse Events, Intolerance or Lack of Efficacy to Synthetic DMARDs That Causes a Change in Treatment Prescription When Used in Routine Clinical Practice |
65.1 | — |
| SECONDARY Percentage of Patients Who Present Adverse Events While on Treatment With Synthetic Disease-modifying Antirheumatic Drug (DMARDs) and Require a Dose Reduction of the Synthetic DMARD in Question |
10.5 | — |
| SECONDARY Percentage of Patients Who Experience Adverse Events While on Treatment With Synthetic DMARDs Which Forces Drug Withdrawal |
16.1 | — |
| SECONDARY Percentage of Patients Who Require an Alternative DMARD Due to Lack of Efficacy, Defined as Primary or Secondary Failure According to the Rheumatologist In-charge of Treatment |
6.9 | — |
| SECONDARY Percentage of Patients Who Receive Subcutaneous Methotrexate |
21.2 | — |
| SECONDARY Exposure Time of Methotrexate |
19.2 | — |
Summary
The purpose of this study is to find patterns in the use of non-biological DMARDs as the initial treatment of RA and how adverse events (AEs), intolerance or lack of efficacy may impact therapeutic decisions in real life in the Spanish Andalusian region.
Eligibility Criteria
Inclusion Criteria
- Patients of both sexes ≥ 18 years.
- Patients diagnosed with RA (according to the American College of Rheumatology (ACR) 2010 criteria) between January 2008 and December 2012 and who have initiated treatment with at least one synthetic DMARD during that period.
- Patients who have given written informed consent for their data to be collected and reviewed.
Exclusion Criteria
- Patients who are already participating in a clinical trial/s at the moment of participation in this study.
- Patients with whom it is suspected there will be insufficient information to complete the study objectives.
Data sourced from ClinicalTrials.gov (NCT02094326). 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.