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

This study has been completed.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
First received: February 26, 2010
Last updated: April 19, 2013
Last verified: April 2013

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

Condition Intervention
Rheumatoid Arthritis
Biological: adalimumab (Humira)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Long-term Surveillance Registry for Biologics (HUMIRA)

Resource links provided by NLM:

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Effectiveness: Disease Activity Score (DAS28), clinical remission. Documentation of adverse events. [ Time Frame: 0, 3, 6, 12, 18 months, followed by 6 months intervals up to 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 5747
Study Start Date: September 2003
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Rheumatoid arthritis patients
Patients with rheumatoid arthritis
Biological: adalimumab (Humira)
40 mg adalimumab (Humira) every other week

Detailed Description:

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 5 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.


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

General population: patients with rheumatoid arthritis


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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01078090

  Show 370 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Study Director: Stefan Simianer, 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: NCT01078090     History of Changes
Other Study ID Numbers: HUM 03-1
Study First Received: February 26, 2010
Last Updated: April 19, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by AbbVie:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 16, 2014