Efficacy and Safety of Adalimumab in Rheumatoid Arthritis Patients in Routine Clinical Practice - Full Text View

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT01078090

Purpose

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:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Adalimumab

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Effectiveness: Disease Activity Score (DAS28), clinical remission. Safety: side effects [ Time Frame: 0, 3, 6, 12, 18 months, followed by 6 months intervals up to 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	5738
Study Start Date:	September 2003
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2014 (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.

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

General population: patients with rheumatoid arthritis

Criteria

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

Contacts

Contact: Gerd Greger, PhD	+49 6122 58-1610	gerd.greger@abbott.com
Contact: Elisabeth Glaser-Caldow	#49 6122 581235	elisabeth.glaser@abbott.com

Show 387 Study Locations

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Bianca Wittig, MD

Abbott Germany, Medical Department

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Medical Department, Wiesbaden Germany ( Dr. Bianca Wittig / Head of Medical Development Immunology (Acting Medical Director) )
ClinicalTrials.gov Identifier:	NCT01078090 History of Changes
Other Study ID Numbers:	HUM-03-1 (5 years)
Study First Received:	February 26, 2010
Last Updated:	June 21, 2010
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by Abbott:

Rheumatoid Arthritis
Safety
Effectiveness

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases

Immune System Diseases
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on September 01, 2010