A Study of the Efficacy and Safety of Tocilizumab for Confirmed Rheumatoid Arthritis (RA) Participants in Clinical Practice

Terminated

• Conditions: Rheumatoid Arthritis
• Interventions: Other: No intervention

• Registration Number: NCT02616328
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-25
• Study First Submitted QC: 2015-11-25
• Study First Posted: 2015-11-26
• Study Start: 2017-01-26
• Primary Completion: 2017-12-12
• Study Completion: 2017-12-12
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-17
• Last Update Posted: 2018-10-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with confirmed rheumatoid arthritis	No intervention	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Mean Change in DAS28	Baseline, Week 12, and Week 24
Mean Change in CDAI	Baseline, Week 12, and Week 24
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
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

Trial Locations

Locations (2)

King Khaled Uni Hospital; Oncology; 🇸🇦 Riyadh, Saudi Arabia

King Fahad Medical City; Gastroentrology; 🇸🇦 Riyadh, Saudi Arabia