Clinical trial NCT02616328: A Study of the Efficacy and Safety of Tocilizumab for Confirmed Rheumatoid Arthritis (RA) Participants in Clinical Practice
Official title: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-11-26
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with confirmed rheumatoid arthritis

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants with a 28-Joint Disease Activity Score (DAS28) < 2.6 at Week 24
timeFrame: Week 24
measure: Number of Participants with Adverse Events
timeFrame: Up to 30 months
Secondary outcomes:
measure: Percentage of Participants with Tender Joint Count-28 Joints (TJC28) < or = 1 at Week 12 and Week 24
timeFrame: Week 12 and Week 24
measure: Percentage of Participants with Swollen Joint Count-28 Joints (SJC28) < or = 1 at Week 12 and Week 24
timeFrame: Week 12 and Week 24
measure: Percentage of Participants with C-Reactive Protein (CRP) < or = 1mg/dL at Week 12 and Week 24
timeFrame: Week 12 and Week 24
measure: Percentage of Participants with Participant Global Health (PGH) < or = 1/10 at Week 12 and Week 24
timeFrame: Week 12 and Week 24
measure: Percentage of Participants with Clinical Disease Activity Index (CDAI) < or = 2.8 at Week 12 and Week 24
timeFrame: Week 12 and Week 24
measure: Percentage of Participants with DAS28 < or = 3.2 at Week 12 and Week 24
timeFrame: Week 12 and Week 24
measure: Percentage of Participants with CDAI < or = 10 at Week 12 and Week 24
timeFrame: Week 12 and Week 24
measure: Percentage of Participants with DAS28 < 2.6 at Week 12
timeFrame: Week 12
measure: Mean Change in DAS28
timeFrame: Baseline, Week 12, and Week 24
measure: Mean Change in CDAI
timeFrame: Baseline, Week 12, and Week 24
measure: Mean Change in TJC
timeFrame: Baseline and Week 24
measure: Mean Change in SJC
timeFrame: Baseline and Week 24
measure: Mean Change in CRP
timeFrame: Baseline and Week 24
measure: Mean Change in PGH
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Khaled Uni Hospital; Oncology
city: Riyadh
country: Saudi Arabia
facility: King Fahad Medical City; Gastroentrology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: