Rheumatoid Arthritis
Conditions
Brief summary
This is a single-arm, open-label, non-randomized, multicenter trial to evaluate the efficacy and safety of using tocilizumab for confirmed rheumatoid arthritis participants in clinical practice.
Interventions
OTHERNo intervention
No intervention administered in this study
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with moderate-to-severe active rheumatoid arthritis (RA) for over 3 months * Started on tocilizumab, with or without previous history of biological treatment
Exclusion criteria
* Pregnant or lactating women * Treated with an investigational drug within 30 days prior to initiation of study drug * Having a condition that, in the opinion of the investigator, could compromise the participant's safety or interfere with the study results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants with a 28-Joint Disease Activity Score (DAS28) < 2.6 at Week 24 | Week 24 |
| Number of Participants with Adverse Events | Up to 30 months |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Tender Joint Count-28 Joints (TJC28) < or = 1 at Week 12 and Week 24 | Week 12 and Week 24 |
| Percentage of Participants with Participant Global Health (PGH) < or = 1/10 at Week 12 and Week 24 | Week 12 and Week 24 |
| Percentage of Participants with Clinical Disease Activity Index (CDAI) < or = 2.8 at Week 12 and Week 24 | Week 12 and Week 24 |
| Percentage of Participants with DAS28 < or = 3.2 at Week 12 and Week 24 | Week 12 and Week 24 |
| Percentage of Participants with CDAI < or = 10 at Week 12 and Week 24 | Week 12 and Week 24 |
| Percentage of Participants with DAS28 < 2.6 at Week 12 | Week 12 |
| Percentage of Participants with Swollen Joint Count-28 Joints (SJC28) < or = 1 at Week 12 and Week 24 | Week 12 and Week 24 |
| Mean Change in CDAI | Baseline, Week 12, and Week 24 |
| Mean Change in TJC | Baseline and Week 24 |
| Mean Change in SJC | Baseline and Week 24 |
| Mean Change in CRP | Baseline and Week 24 |
| Mean Change in PGH | Baseline and Week 24 |
| Mean Change in DAS28 | Baseline, Week 12, and Week 24 |
| Percentage of Participants with C-Reactive Protein (CRP) < or = 1mg/dL at Week 12 and Week 24 | Week 12 and Week 24 |
Countries
Saudi Arabia
Outcome results
None listed