Protocol IM101042: A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept vs. Placebo on a Background of Oral Glucocorticosteroids in the Treatment of Subjects with Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus Flares.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000692639

Acronym

Not applicable.

Enrollment

180

Registered

2005-10-27

Start date

2005-10-01

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 plus Prednisone or Prednisone equivalent for 12-month period OR placebo plus Prednisone or Prednisone equivalent for 12-month period. Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Single Group 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 No maximum

Healthy volunteers

Inclusion criteria

1. Subjects must be diagnosed with SLE and be experiencing an active lupus flare in at least one of three organ systems: skin (discoid lesions), inflammation of the lining of the heart (pericarditis), or inflammation of the lining of the lung (pleuritis/pleurisy); or inflammation of more than 4 joints within 14 days of a screening visit. 2. Stable dose of prednisone (<30mg) for at least one month.

Exclusion criteria

1. Subjects experiencing an active lupus flare in the kidney or central nervous systems. 2. Treatment with a stable dose of azathioprine, mycophenolate mofetil, hydroxychloroquine, chloroquine, or methotrexate for less than three months prior to the study. 3. Subjects with active viral or bacterial infections. 4. Subjects with any other autoimmune disease as a main diagnosis. 5. Prior treatment with rituximab.

Outcome results