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| Tracking Information | |||||||||
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| First Received Date ICMJE | March 1, 2010 | ||||||||
| Last Updated Date | December 29, 2011 | ||||||||
| Start Date ICMJE | January 2006 | ||||||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01079182 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Safety and Effectiveness of Adalimumab (Humira) in Patients With Ankylosing Spondylitis in Clinical Routine | ||||||||
| Official Title ICMJE | A Basic Documentation to Demonstrate Long Term Efficacy and Safety of Humira in Patients With Ankylosing Spondylitis Under Conditions of Daily Practice | ||||||||
| Brief Summary | The objectives of this PMOS are to:
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| Detailed Description | This basic documentation is a PMOS according to German Drug Law, applicable for patients with moderate to severe active ankylosing spondylitis (AS) who have insufficient controlled AS under current therapy and are eligible for HUMIRA therapy. Patients start treatment with HUMIRA in normal clinical settings in Germany. Patients must be at least 18 years of age. Enrolled patients will prospectively followed during therapy with HUMIRA prescribed by his/her physician. A patient may only be enrolled in the PMOS only once. Approximately 250 physicians (rheumatologists/orthopedists) will participate in the PMOS and each physician may enroll all patients treated with HUMIRA for a period of one year. Patients will be followed for seven consecutive visits performed on at the regular visit interval for AS patients over a period of two years. Physicians must determine the appropriate therapy for each patient. Once the physician has determined that the patient qualifies for HUMIRA therapy, and the patient has agreed to be included in the AWB, the patient's baseline (T0) demographic data, pertinent past medical history and physical findings will be reported in the baseline (T0) Data Report Form. The physician will then follow the patient via regular office visits as determined by the physician. According to the recommendations of the German Society of Rheumatology this these visits should ideally be performed at 3, 6, 9, 12, 18 and 24 months. |
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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 | Clinical Routine Patients with ankylosing spondylitis |
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| Condition ICMJE | Ankylosing Spondylitis | ||||||||
| Intervention ICMJE | Drug: adalimumab (Humira)
40 mg every other week.
Other Names:
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| Comparison Groups | Ankylosing spondylitis patients
Patients with Ankylosing Spondylitis
Intervention: Drug: 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 | 3900 | ||||||||
| Estimated Completion Date | September 2013 | ||||||||
| Estimated Primary Completion Date | September 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 | Germany | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01079182 | ||||||||
| Other Study ID Numbers ICMJE | P10-147 | ||||||||
| 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 | November 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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