drugset / Trial / NCT00769028
AIMSPRO in Established Diffuse Cutaneous Systemic Sclerosis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
To study the safety and tolerability of a hyperimmune goat serum product (AIMSPRO) in the treatment of systemic sclerosis (SSc) through a period of 26 weeks of study participation. The secondary objective of the study is to assess the efficacy of AIMSPRO as a therapeutic agent for SSc using inter alia the SSc-HAQ questionnaire and the modified Rodnan skin score.
Timeline
- Start
- 2008-12
- Primary completion
- 2011-02
- Completion
- 2011-09
Publications
- Quillinan N, Clark KE, Youl B, Vernes J, McIntosh D, Haq S, Denton CP. Multiplex serum protein analysis reveals potential mechanisms and markers of response to hyperimmune caprine serum in systemic sclerosis. Arthritis Res Ther. 2017 Mar 7;19(1):45. doi: 10.1186/s13075-017-1252-x.
- Quillinan NP, McIntosh D, Vernes J, Haq S, Denton CP. Treatment of diffuse systemic sclerosis with hyperimmune caprine serum (AIMSPRO): a phase II double-blind placebo-controlled trial. Ann Rheum Dis. 2014 Jan;73(1):56-61. doi: 10.1136/annrheumdis-2013-203674. Epub 2013 Sep 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hyperimmune caprine serum | Unknown | 1 ml | Subcutaneous |