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

AbbVie

Status: Completed

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT01076205

P11-973

Details and patient eligibility

About

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.

Enrollment: 7,229 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

7,229 participants in 1 patient group

Adalimumab

Description:

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