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OpenTrials
Completed

NCT Number: NCT00234845

Adalimumab in Combination With Methotrexate vs Methotrexate Alone in Early Rheumatoid Arthritis

The purpose of the study is to evaluate the effectiveness of adalimumab in combination with methotrexate compared to methotrexate alone on work disability in subjects with early rheumatoid arthritis

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Global Medical Information - Abbott

Abbott Park, Illinois, 60064, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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-revised ACR criteria
  • Subject must be in paid employment
  • Subject has self-reported work impairment since onset of symptoms

Exclusion criteria

  • A subject has chronic arthritis diagnosed before age 16 years.
  • Subject has been on preceding treatment with methotrexate Subject unable to withdraw from current DMARDs
  • Subject has preceding treatment with any biological TNF antagonist
  • 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

Treatment and study plan

Adalimumab

Drug

methotrexate

Drug

Primary outcomes

  1. Job loss measurement

Secondary outcomes

  1. Job productivity measurements

  2. Patient reported outcomes

  3. DAS28

  4. Safety parameters

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

A Multi-Centre Randomized, Double-Blind Study Comparing Adalimumab (D2E7) Plus Methotrexate With Placebo Plus Methotrexate on Work Disability in Subjects With Early Rheumatoid Arthritis

Important dates

Study start
2003
First posted
Oct 10, 2005
Registry last updated
Aug 29, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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