An Observational Study in Clinical Practice Management of Patients With Biological Drugs in Monotherapy
This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01664117
First received: August 8, 2012
Last updated: May 7, 2013
Last verified: May 2013
| Tracking Information | |||||
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| First Received Date ICMJE | August 8, 2012 | ||||
| Last Updated Date | May 7, 2013 | ||||
| Start Date ICMJE | June 2012 | ||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Clinical and demographic patient characteristics in clinical practice at initiation of treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01664117 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | An Observational Study in Clinical Practice Management of Patients With Biological Drugs in Monotherapy | ||||
| Official Title ICMJE | Study of Clinical Management and Profile of Patients With Rheumatoid Arthritis Treated With Biological Therapies in Monotherapy | ||||
| Brief Summary | This observational multicenter study will evaluate the management of disease and safety in clinical practice in patients with moderate to severe rheumatoid arthritis receiving any biological therapies in monotherapy. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Patients with moderate to severe rheumatoid arthritis |
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| Condition ICMJE | Rheumatoid Arthritis | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Cohort | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | July 2013 | ||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Spain | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01664117 | ||||
| Other Study ID Numbers ICMJE | ML28356 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Hoffmann-La Roche | ||||
| Study Sponsor ICMJE | Hoffmann-La Roche | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Hoffmann-La Roche | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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