A Phase II Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients With Undifferentiated Arthritis Who Are at High Risk for the Development of RA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000785606

Acronym

IM101-046

Enrollment

Registered

2005-12-09

Start date

2006-01-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug: Abatacept for the first 6 months, then 18 months oberservation. Study Design: Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

Diagnosis of undifferentiated arthritis Clinical synovitis of two or more joints At least one but not more than three of the criteria for diagnosis of RA (1987). No prior disease modifying anti-rheumatic drugs (DMARDs)/biologics. Duration of disease must be 18 months or less. Positive for antibodies against cyclic citrullinated peptides.

Exclusion criteria

Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy. Men unwilling to use an adequate method of contraception. Active vasculitis of a major organ system. Severe or recurrent bacterial infection. History of cancer in the last five years except certain skin cancers. Herpes zoster that resolved less than 2 months prior to enrollment.

Outcome results