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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02616328
• Other study ID #: ML29936
• Status: Terminated
• Start date: January 26, 2017
• Est. completion date: December 12, 2017

Study information

• Verified date: October 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 12, 2017
• Est. primary completion date: December 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• No intervention
No intervention administered in this study

Locations

Country	Name	City	State
Saudi Arabia	King Fahad Medical City; Gastroentrology	Riyadh
Saudi Arabia	King Khaled Uni Hospital; Oncology	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with a 28-Joint Disease Activity Score (DAS28) < 2.6 at Week 24		Week 24
Primary	Number of Participants with Adverse Events		Up to 30 months
Secondary	Percentage of Participants with Tender Joint Count-28 Joints (TJC28) < or = 1 at Week 12 and Week 24		Week 12 and Week 24
Secondary	Percentage of Participants with Swollen Joint Count-28 Joints (SJC28) < or = 1 at Week 12 and Week 24		Week 12 and Week 24
Secondary	Percentage of Participants with C-Reactive Protein (CRP) < or = 1mg/dL at Week 12 and Week 24		Week 12 and Week 24
Secondary	Percentage of Participants with Participant Global Health (PGH) < or = 1/10 at Week 12 and Week 24		Week 12 and Week 24
Secondary	Percentage of Participants with Clinical Disease Activity Index (CDAI) < or = 2.8 at Week 12 and Week 24		Week 12 and Week 24
Secondary	Percentage of Participants with DAS28 < or = 3.2 at Week 12 and Week 24		Week 12 and Week 24
Secondary	Percentage of Participants with CDAI < or = 10 at Week 12 and Week 24		Week 12 and Week 24
Secondary	Percentage of Participants with DAS28 < 2.6 at Week 12		Week 12
Secondary	Mean Change in DAS28		Baseline, Week 12, and Week 24
Secondary	Mean Change in CDAI		Baseline, Week 12, and Week 24
Secondary	Mean Change in TJC		Baseline and Week 24
Secondary	Mean Change in SJC		Baseline and Week 24
Secondary	Mean Change in CRP		Baseline and Week 24
Secondary	Mean Change in PGH		Baseline and Week 24