Assessment of the Safety of Adalimumab in Rheumatoid Arthritis Patients Showing Rapid Progression of Structural Damage of the Joints, Who Have no Prior History of Treatment With Disease-modifying Anti-rheumatic Drugs or Biological Agents

AbbVie

Status: Completed

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT01783730

P13-983

Details and patient eligibility

About

This study was conducted to examine the safety profile and the effectiveness in daily clinical practice of adalimumab in rheumatoid arthritis participants showing rapid progression of structural damage of the joints, who had no prior history of treatment with disease-modifying anti-rheumatic drugs or biological agents.

Full description

This was a multicenter, prospective, observational study of adalimumab. Each participant enrolled when initiating adalimumab treatment and was to be followed up for 24 weeks or until discontinuation of the drug.

Enrollment: 163 patients

Sex: All

Ages: 15 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. High disease activity, with poor prognostic factors (e.g., rheumatoid factor [RF]-positive, anti-cyclic citrullinated peptide [CCP] antibody-positive, or bone erosion)
2. Combination of adalimumab and methotrexate will be started
3. No prior history of treatment with disease-modifying anti-rheumatic drugs
4. No prior history of treatment with biological agents
5. Adalimumab dosed according to the registered product label
6. Signed informed consent

Exclusion criteria

There were no specific exclusion criteria.

Trial design

163 participants in 1 patient group

Participants with high rheumatoid arthritis disease activity

Description:

Participants who received adalimumab treatment