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

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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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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