Safety and Effectiveness of Adalimumab (Humira) in Patients With Ankylosing Spondylitis in Clinical Routine
The objectives of this PMOS are to:
- document clinical practice patterns for treating patients with ankylosing spondylitis
- demonstrate long-term efficacy and safety of HUMIRA in patients with ankylosing spondylitis under routine conditions.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Basic Documentation for Humira Treated Patients With Ankylosing Spondylitis (AS)|
- Document clinical practice patterns for treating patients with ankylosing spondylitis. [ Time Frame: 3, 6, 9, 12, 18, 24 months ] [ Designated as safety issue: Yes ]
- Demonstrate long-term efficacy and safety of HUMIRA in patients with ankylosing spondylitis under routine conditions. [ Time Frame: 3, 6, 9, 12, 18, 24 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2006|
|Study Completion Date:||May 2014|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Ankylosing spondylitis patients
Patients with Ankylosing Spondylitis
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01079182
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|Study Director:||Bianca Wittig, MD||AbbVie Deutschland GmbH & Co. KG, Medical Department|