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Efficacy and Safety of Adalimumab in Patients With Rheumatoid Arthritis in Routine Clinical Practice

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01077258
First received: February 25, 2010
Last updated: April 8, 2013
Last verified: April 2013
History of Changes

February 25, 2010
April 8, 2013
April 2006
March 2013   (final data collection date for primary outcome measure)
Effectiveness: Disease Activity Score (DAS28), clinical remission. Documentation of adverse events. [ Time Frame: Month 0, 3, 6, 9, 12, 18, 24 ] [ Designated as safety issue: No ]
Effectiveness: DAS28 (Disease Activity Score), clinical remission. Safety: side effects [ Time Frame: Month 0, 3, 6, 9, 12, 18, 24 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01077258 on ClinicalTrials.gov Archive Site
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Efficacy and Safety of Adalimumab in Patients With Rheumatoid Arthritis in Routine Clinical Practice
Two Years Documentation of Patients With Rheumatoid Arthritis

Observation of safety, tolerability and effectiveness of Humira therapy in a large patient collective under everyday clinical conditions over a long-time period.

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 2 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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Community sample: patients with rheumatoid arthritis
Rheumatoid Arthritis
Biological: adalimumab (Humira)
40 mg adalimumab (Humira) every other week
Rheumatoid arthritis patients
Patients with rheumatoid arthritis
Intervention: Biological: adalimumab (Humira)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4206
March 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Moderate to severe active rheumatoid arthritis in adults with insufficient response to disease-modifying antirheumatic drugs, inclusive methotrexate
  • Moderate to severe active rheumatoid arthritis in adults who have not been treated with methotrexate before. In case of incompatibility with methotrexate, Humira can be used as monotherapy

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01077258
P10-448
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Stefan Simianer, MD AbbVie Deutschland GmbH & Co. KG, Medical Department
AbbVie
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP