Clinical trial · Observational
Comparative Effectiveness Of Tumor Necrosis Factor Inhibitors And Tofacitinib Use In Earlier Lines Of Therapy And Use As Monotherapy.
Comparative Effectiveness of Tumor Necrosis Factor (TNF) Inhibitors and Tofacitinib, Overall, by Line of Therapy and by Combination Therapy
NCT04721821CI-TRIAL-00076018completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is to investigate if there has been a shift in treatment with tofacitinib, assessing real world patient data and entered in the Corrona registry between 2016 and 2020.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Arthritis Rheumatoid | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tofacitinib | Drug | Tofacitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Patients with Rheumatoid Arthritis (RA)
- interventionNames
- Drug: Tofacitinib
Primary outcomes (10)
- measure
- Number of Participants Who Achieved Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) at Month 6: Tofacitinib Overall Versus TNFis Overall
- timeFrame
- Month 6 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
- description
- CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI less than or equal to (\<=)10 in participants with moderate or high disease activity CDAI greater than (\>) 10 at baseline. Propensity score method was used for analysis of the outcome measure.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * RA patients in Corrona initiating tofacitinib or a TNF biologic (adalimumab, etanercept, infliximab, golimumab, certolizumab pegol) after 06 November 2012 (market approval of Tofacitinib) during follow-up in Corrona with no prior use of tofacitinib. Only the patient's first initiation after 06 November 2012 will be included in the analysis * Have a 6 and / or 12-month follow-up visit (with +/- 2 month window) * Have Clinical Disease Activity Index (CDAI) measures at baseline and at the follow-up visit Exclusion Criteria: * Patients who have not failed methotrexate (MTX) or another csDMARD (ie 1st line initiators)
References
Publications (0)
Data not yet available
No reference posted for this study.