NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT01770834

CompletedN/A

Sponsor: Hoffmann-La Roche

Conditions: Rheumatoid Arthritis

Countries: Kuwait, Lebanon, Qatar, United Arab Emirates

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.

Eligibility overview

Sex: ALL

Age: 21 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (12)

Safat, Kuwait
Beirut, Lebanon
Beirut, Lebanon
Beirut, Lebanon
Beirut, Lebanon
Beirut, Lebanon
Byblos, Lebanon
Saida, Lebanon
Tripoli, Lebanon
Doha, Qatar
Dubai, United Arab Emirates
Dubai, United Arab Emirates