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| Sponsor: | Abbott |
|---|---|
| Information provided by: | Abbott |
| ClinicalTrials.gov Identifier: | NCT01079182 |
Purpose
The objectives of this PMOS are to:
| Condition | Intervention |
|---|---|
|
Ankylosing Spondylitis |
Drug: adalimumab (Humira) |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | A Basic Documentation to Demonstrate Long Term Efficacy and Safety of Humira in Patients With Ankylosing Spondylitis Under Conditions of Daily Practice |
| Estimated Enrollment: | 2531 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Ankylosing spondylitis patients
Patients with Ankylosing Spondylitis
|
Drug: adalimumab (Humira)
40 mg every other week.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Clinical Routine Patients with ankylosing spondylitis
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Gerd Greger, PhD | +49 612205801610 | gerd.greger@abbott.com |
| Contact: Elisabeth Glaser-Caldow | 49 6122 581235 | elisabeth.glaser@abbott.com |
Show 416 Study Locations| Study Director: | Bianca Wittig, MD | Abbott Germany, Wiesbaden |
More Information
| Responsible Party: | Medical Department, Wiesbaden Germany ( Dr. Bianca Wittig / Head of Medical Development Immunology (Acting Medical Director) ) |
| ClinicalTrials.gov Identifier: | NCT01079182 History of Changes |
| Other Study ID Numbers: | P10-147 |
| Study First Received: | March 1, 2010 |
| Last Updated: | June 21, 2010 |
| Health Authority: | Germany: Paul-Ehrlich-Institut |
|
Ankylosing Spondylitis Humira Safety Efficacy Daily practice |
|
Spondylitis Spondylitis, Ankylosing Bone Diseases, Infectious Infection Bone Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthropathies Spondylarthritis |
Ankylosis Joint Diseases Arthritis Adalimumab Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents |