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Open-Label Steroid Reduction Study of Adalimumab With Methotrexate in Patients With Active Rheumatoid Arthritis

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Abbott

Status and phase

Terminated
Phase 4

Conditions

Rheumatoid Arthritis

Treatments

Drug: methotrexate
Drug: adalimumab (up to 9 months exposure)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00233558
FRAN-04-002

Details and patient eligibility

About

The purpose of the study is to evaluate the clinical efficacy of scheduled versus free reduction of steroid treatment in patients with active RA treated with adalimumab + MTX

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-revised ACR criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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