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

October 17, 2018 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11472
        • King Khaled Uni Hospital; Oncology
      • Riyadh, Saudi Arabia, 11525
        • King Fahad Medical City; Gastroentrology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants with confirmed rheumatoid arthritis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants with confirmed rheumatoid arthritis
Other: No intervention
No intervention administered in this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with a 28-Joint Disease Activity Score (DAS28) < 2.6 at Week 24
Time Frame: Week 24
Week 24
Number of Participants with Adverse Events
Time Frame: Up to 30 months
Up to 30 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with Tender Joint Count-28 Joints (TJC28) < or = 1 at Week 12 and Week 24
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Week 12 and Week 24
Week 12 and Week 24
Percentage of Participants with DAS28 < or = 3.2 at Week 12 and Week 24
Time Frame: Week 12 and Week 24
Week 12 and Week 24
Percentage of Participants with CDAI < or = 10 at Week 12 and Week 24
Time Frame: Week 12 and Week 24
Week 12 and Week 24
Percentage of Participants with DAS28 < 2.6 at Week 12
Time Frame: Week 12
Week 12
Mean Change in DAS28
Time Frame: Baseline, Week 12, and Week 24
Baseline, Week 12, and Week 24
Mean Change in CDAI
Time Frame: Baseline, Week 12, and Week 24
Baseline, Week 12, and Week 24
Mean Change in TJC
Time Frame: Baseline and Week 24
Baseline and Week 24
Mean Change in SJC
Time Frame: Baseline and Week 24
Baseline and Week 24
Mean Change in CRP
Time Frame: Baseline and Week 24
Baseline and Week 24
Mean Change in PGH
Time Frame: Baseline and Week 24
Baseline and Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2017

Primary Completion (Actual)

December 12, 2017

Study Completion (Actual)

December 12, 2017

Study Registration Dates

First Submitted

November 25, 2015

First Submitted That Met QC Criteria

November 25, 2015

First Posted (Estimate)

November 26, 2015

Study Record Updates

Last Update Posted (Actual)

October 18, 2018

Last Update Submitted That Met QC Criteria

October 17, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML29936

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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