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

AbbVie

Status: Completed

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT01077258

P10-448

Details and patient eligibility

About

Observation of safety, tolerability and effectiveness of adalimumab (Humira) therapy in a large patient collective under everyday clinical conditions over 2 years.

Full description

Patients with rheumatoid arthritis who started treatment with adalimumab in a normal clinical setting according to the product label were documented. The follow-up observation period was for 2 years and focused on safety information and maintenance of efficacy during a normal clinical setting. Follow-up with participants was via regular office visits at intervals as determined by routine clinical practice or as recommended by national guidelines.

Enrollment: 4,208 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate to severe active rheumatoid arthritis in adults with insufficient response to disease-modifying antirheumatic drugs, including 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

4,208 participants in 1 patient group

Rheumatoid arthritis

Description:

Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.