Quality of Life Study With Adalimumab in Rheumatoid Arthritis

Abbott

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Adalimumab; Drug: Methotrexate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00234936

MEXI -P01-03

ESCALAR

Details and patient eligibility

About

The purpose of the study is to evaluate the ability of adalimumab combined with methotrexate to improve the quality of life in patients with active RA.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is age 18 or older and in good health (Investigator discretion) with a recent stable medical history
• Subject has a diagnosis of rheumatoid arthritis as defined by the 1987 ACR criteria
• Subjects with treatment failure criteria to Mtx or Mtx + another DMARD

Exclusion criteria

• Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
• Female subject who is pregnant or breast-feeding or considering becoming pregnant
• Previous treatment with approved biological agents (etanercept, infliximab, anakinra) in the last 2 months

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)