Who is sponsoring NCT00442611?

NCT00442611 is sponsored by Stanford University.

What condition does NCT00442611 study?

NCT00442611 studies Scleroderma, Diffuse, Scleroderma, Systemic.

What drugs are being tested in NCT00442611?

Interventions: Abatacept, Placebo.

What is the status of NCT00442611?

NCT00442611 is currently COMPLETED.

Last reviewed 2017-09-28 · How we verify

A Pilot Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Systemic Sclerosis

NCT00442611 Phase 1/Phase 2 COMPLETED Results posted

Systemic sclerosis (scleroderma) is an autoimmune connective tissue disease that involves the skin and other internal organs for which there are few effective treatment options. We hypothesize that treatment with abatacept, a new therapy recently approved for the treatment of rheumatoid arthritis, may reduce the progression of skin thickening and fibrosis in people with scleroderma.

Details

Lead sponsor	Stanford University
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	10
Start date	2008-11
Completion	2011-06

Conditions

Scleroderma, Diffuse
Scleroderma, Systemic

Interventions

Abatacept
Placebo

Primary outcomes

Change in Modified Rodnan Skin Score — 6 months
Modified Rodnan Skin Score measures skin thickness and is the sum of scores from 17 surface anatomic areas rated on a 0-3 scale (0=normal skin; 1=mild thickness; 2=moderate thickness; 3=severe thickness with inability to pinch the skin into a fold). Total modified Rodnan Skin Score ranges from 0 (best possible outcome) to 51 (worst possible outcome).

Countries

United States