Safety and Effectiveness of Adalimumab (Humira) in Patients With Ankylosing Spondylitis in Clinical Routine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01079182
First received: March 1, 2010
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

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.

Condition
Ankylosing Spondylitis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Basic Documentation for Humira Treated Patients With Ankylosing Spondylitis (AS)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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 ]

Enrollment: 5494
Study Start Date: January 2006
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Ankylosing spondylitis patients
Patients with Ankylosing Spondylitis

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Clinical Routine Patients with ankylosing spondylitis.

Criteria

Inclusion Criteria:

  • Active, ankylosing spondylitis in adults with insufficient response to conventional therapy.

Exclusion Criteria:

  • Hypersensitivity against the drug or one of the other ingredients
  • Active tuberculosis or other severe infections (e.g. sepsis and opportunistic infections)
  • Moderate to severe cardiac insufficiency.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01079182

  Show 357 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Bianca Wittig, MD AbbVie Deutschland GmbH & Co. KG, Medical Department
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01079182     History of Changes
Other Study ID Numbers: P10-147
Study First Received: March 1, 2010
Last Updated: May 16, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by AbbVie:
Daily practice
Humira
Efficacy
Safety
Ankylosing Spondylitis

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Ankylosis
Arthritis
Bone Diseases
Bone Diseases, Infectious
Infection
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthritis
Spondylarthropathies

ClinicalTrials.gov processed this record on October 23, 2014