A Prospective, Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01770834
• Collaborator: (none)
• Enrollment: 100
• Locations: 12
• Actual Duration (Months): 45.3
• Patients Per Site: 8.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This prospective, observational study will evaluate the efficacy, safety and tolerability of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have had an inadequate response or are intolerant to one or more conventional disease-modifying anti-rheumatic drugs. Data will be collected from patients initiated on RoActemra/Actemra treatment according to the local label at baseline, Weeks 4, 12 and 24, and at 3 and 6 months after the last dose of study drug.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective, Non-interventional Multi-center Observational Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis in Routine Practice
• Actual Study Start Date: Apr 18, 2013
• Actual Primary Completion Date: Jan 25, 2017
• Actual Study Completion Date: Jan 25, 2017

Arms and Interventions

Arm	Intervention/Treatment
Cohort

Outcome Measures

Primary Outcome Measures

1. Safety: Incidence of adverse events [approximately 3 years]

Secondary Outcome Measures

1. Percentage of patients achieving a clinically meaningful improvement in disease activity: DAS28 reduction of at least 1.2 units, low disease activity (DAS28 </= 3.2) or remission (DAS28 <2.6) [approximately 3 years]

2. Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment [approximately 3 years]

3. Treatment regimens: Concomitant medications [approximately 3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult patients, >/= 21 years of age

• Moderate to severe active rheumatoid arthritis (DAS28 >/= 3.2)

• Inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs)

• Initiated on RoActemra/Actemra treatment in accordance with the prescribing information

Exclusion Criteria:

• Pregnant or lactating women

• Contra-indication to RoActemra/Actemra treatment according to the local labelling

• Previous treatment with tocilizumab

• Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra

• Women of childbearing potential not using effective methods of contraception as defined by protocol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Safat		Kuwait	13041
2		Beirut		Lebanon	11-236
3		Beirut		Lebanon	470 Hazmieh
4		Beirut		Lebanon	961
5		Beirut		Lebanon	99999
6		Beirut		Lebanon
7		Jbeil		Lebanon	1401
8		Saida		Lebanon	652
9		Tripoli		Lebanon	371 Tripoli
10		Doha		Qatar	3050
11		Dubai		United Arab Emirates	P.O. Box 31500
12		Dubai		United Arab Emirates	P.O. Box 8179

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT01770834
• Other Study ID Numbers: ML25533
• First Posted: Jan 18, 2013
• Last Update Posted: Mar 2, 2018
• Last Verified: Feb 1, 2018

• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid

Study Results

No Results Posted as of Mar 2, 2018