A Retrospective Observational Study on Compliance in Patients With Rheumatoid Arthritis on Treatment With RoActemra/Actemra (Tocilizumab) in Clinical Practice (REMISSION II)
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01649817
First received: July 23, 2012
Last updated: June 3, 2013
Last verified: June 2013
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Purpose
This multicenter, retrospective observational study will evaluate compliance an reasons for withdrawal in patients with moderate to severe active rheumatoid arthritis on treatment with intravenous RoActemra/Actemra (tocilizumab) in daily clinical practice. Data will be collected from each eligible patient over a period of 6 months.
| Condition |
|---|
|
Rheumatoid Arthritis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Multicenter REtrospective Study to Evaluate coMpliance to Therapy and Drug survIval of Tocilizumab (TCZ) in patientS With Moderate to Severe actIve rheumatOid Arthritis in routiNe Daily Clinical Practice (REMISSION II Study) |
Resource links provided by NLM:
MedlinePlus related topics:
Rheumatoid Arthritis
Drug Information available for:
Tocilizumab
U.S. FDA Resources
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Percentage of patients on RoActemra/Actemra at 6 months after initiating treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Frequency of withdrawal (according to reasons) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Frequency of dose modifications [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Change in disease activity (DAS28) [ Time Frame: from baseline to Month 6 or withdrawal, whichever comes first ] [ Designated as safety issue: No ]
| Enrollment: | 182 |
| Study Start Date: | May 2012 |
| Study Completion Date: | May 2013 |
| Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Cohort |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Rheumatoid arthritis patients suitable for treatment with RoActemra/Actemra according to SPC
Criteria
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Moderate to severe rheumatoid arthritis according to the revised 1987 ACR criteria at baseline
- RoActemra/Actemra treatment must have been initiated 6 months prior to ICF signing
- Patient eligible according to the summary of product characteristics (SPC) and routine clinical practice/European recommendations for the use of biologic DMARDs for the treatment of rheumatoid arthritis
Exclusion Criteria:
- Rheumatic autoimmune disease other than RA
- Participation in interventional clinical trials during the observational period
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01649817
Locations
| Greece | |
| Agia Paraskevi, Greece, 15342 | |
| Agios Dimitrios, Greece, 17343 | |
| Argiroupoli, Greece, 16452 | |
| Athens, Greece, 11473 | |
| Athens, Greece, 15562 | |
| Athens, Greece | |
| Athens, Greece, 11521 | |
| Chalandri, Greece | |
| Chania, Greece, 73134 | |
| Eleusina, Greece, 19200 | |
| Herakleio, Greece, 71307 | |
| Ioannina, Greece, 45500 | |
| Kifisia, Greece | |
| Korinthos, Greece, 20100 | |
| Peristeri, Greece, 12934 | |
| Peuki, Greece, 15121 | |
| Rethymno, Greece, 74100 | |
| Serres, Greece, 62122 | |
| Thessaloniki, Greece, 54623 | |
| Thessaloniki, Greece, 54624 | |
| Thessaloniki, Greece, 54622 | |
| Thessaloniki, Greece | |
| Thessaloniki, Greece, 54621 | |
| Volos, Greece, 38221 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01649817 History of Changes |
| Other Study ID Numbers: | ML28258 |
| Study First Received: | July 23, 2012 |
| Last Updated: | June 3, 2013 |
| Health Authority: | Greece: Ministry of Health and Welfare |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013