Study Stopped
Planned recruitment target not reached
A Study of the Efficacy and Safety of Tocilizumab for Confirmed Rheumatoid Arthritis (RA) Participants in Clinical Practice
A Multicenter, Prospective, Observational, Non-Interventional Study Evaluating the Efficacy and Safety of Using Tocilizumab (TCZ) for Confirmed Rheumatoid Arthritis (RA) Patients In Clinical Practice
1 other identifier
observational
8
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2017
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2015
CompletedFirst Posted
Study publicly available on registry
November 26, 2015
CompletedStudy Start
First participant enrolled
January 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 12, 2017
CompletedOctober 18, 2018
October 1, 2018
11 months
November 25, 2015
October 17, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (14)
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 Swollen Joint Count-28 Joints (SJC28) < or = 1 at Week 12 and Week 24
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
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
- +9 more secondary outcomes
Study Arms (1)
Participants with confirmed rheumatoid arthritis
Interventions
No intervention administered in this study
Eligibility Criteria
Participants with confirmed rheumatoid arthritis
You may qualify if:
- Diagnosed with moderate-to-severe active rheumatoid arthritis (RA) for over 3 months
- Started on tocilizumab, with or without previous history of biological treatment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
King Khaled Uni Hospital; Oncology
Riyadh, 11472, Saudi Arabia
King Fahad Medical City; Gastroentrology
Riyadh, 11525, Saudi Arabia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2015
First Posted
November 26, 2015
Study Start
January 26, 2017
Primary Completion
December 12, 2017
Study Completion
December 12, 2017
Last Updated
October 18, 2018
Record last verified: 2018-10