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| Tracking Information | |||||||||
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| First Received Date ICMJE | February 26, 2010 | ||||||||
| Last Updated Date | December 1, 2011 | ||||||||
| Start Date ICMJE | September 2003 | ||||||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Effectiveness: Disease Activity Score (DAS28), clinical remission. Safety: side effects [ Time Frame: 0, 3, 6, 12, 18 months, followed by 6 months intervals up to 5 years ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01078090 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Efficacy and Safety of Adalimumab in Rheumatoid Arthritis Patients in Routine Clinical Practice | ||||||||
| Official Title ICMJE | Long-term Surveillance Registry for Biologics (HUMIRA) | ||||||||
| Brief Summary | Observation of safety, tolerability and effectiveness of HUMIRA therapy in a large patient collective under everyday clinical conditions over a long-time period. |
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| Detailed Description | Patients who have Rheumatoid Arthritis and start treatment with HUMIRA in normal clinical settings according to label are documented. The follow-up observation period is planned for 5 years and is focused on safety information and maintenance of efficacy during normal clinical settings. The physicians will follow-up the patient via regular office visits at intervals as determined by routine clinical practice or as recommended by national guidelines. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Biospecimen | |||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | General population: patients with rheumatoid arthritis |
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| Condition ICMJE | Rheumatoid Arthritis | ||||||||
| Intervention ICMJE | Biological: adalimumab (Humira)
40 mg adalimumab (Humira) every other week
Other Names:
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| Comparison Groups | Rheumatoid arthritis patients
Patients with rheumatoid arthritis
Intervention: Biological: adalimumab (Humira) |
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| Publications * | |||||||||
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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 | 5738 | ||||||||
| Estimated Completion Date | December 2014 | ||||||||
| Estimated Primary Completion Date | December 2014 (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 | Germany | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01078090 | ||||||||
| Other Study ID Numbers ICMJE | HUM-03-1 (5 years) | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | ( Abbott ) | ||||||||
| Study Sponsor ICMJE | Abbott | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Abbott | ||||||||
| Verification Date | October 2011 | ||||||||
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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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