Safety and Effect on Quality of Life/Work Productivity of Humira in Patients With Rheumatoid Arthritis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7229 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-12

Study Completion Date

2017-09-14

Brief Summary

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The AGIL study was designed to evaluate the effectiveness and safety of adalimumab over 5 years in routine daily clinical practice in Germany, with a focus on the impact of therapy on employment-related outcomes.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Adalimumab

Adults with moderate to severe active rheumatoid arthritis (RA) who initiated adalimumab therapy during routine clinical care.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No