A double-blind placebo-controlled pilot study of safety and tolerability of AIMSPRO® in established diffuse cutaneous systemic sclerosis

Completed

• Conditions: Diffuse cutaneous systemic sclerosis; Musculoskeletal Diseases; Systemic sclerosis

• Registration Number: ISRCTN54813778
• Lead Sponsor: Daval International Ltd (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-24
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Males and females aged 18 years and older
2. Must fulfil 1980 preliminary classification criteria for systemic sclerosis of the American Rheumatism Association
3. Diffuse cutaneous systemic sclerosis, as evidenced by skin sclerosis proximal to the elbows or knees and absence of the anti-centromere autoantibody
4. Three years must have elapsed since the first non-Raynaud's manifestation
5. Men and women of chilbdearing potential must use adequate birth control measures for the duration of the study and should continue such precautions for six months after receiving the last injection of AIMSPRO®
6. Hb >8.5 g/dL
7. White blood cell (WBC) >3.5 x 10^9/L
8. Platelets >100 x 10^9/L
9. Serum glutamic-oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) and alkaline phosphatatse levels must be within twice the upper limit of normal range

Exclusion Criteria

1. Woman who are pregnant, nursing or planning pregnancy within one and a half years after screening
2. Use of any Investigational Medicinal Product (IMP) within one month prior to screening or within five half-lives of the IMP, whichever is longer
3. Use of a putative disease modifying drug within one month of screening
4. Treatment with any medication targeted at reducing tumour necrotising factor (TNF) within three months of screening
5. Previous administration of AIMSPRO®
6. History of known allergy to animal proteins
7. Serious infections in the last three months
8. Active Hepatitis B or C
9. Active tuberculosis
10. Opportunistic infections within the last six months
11. History or suggestive signs of lymphoproliferative disease
12. Known recent substance abuse
13. Poor tolerability of venesection or poor access
14. Presence of a transplanted organ (other than a corneal transplant of >3 months duration)
15. Immunosuppressive therapy within one month of screening
16. Malignancy within the past five years
17. Signs or symptoms of severe, progressive or uncontrolled renal, hepatic, haematologic, gastrointestinal, endocrine, pulmonary, cardiac or neurological disease
18. Myocardial infarction, uncontrolled cardiac failure, unstable angina or uncontrolled systemic hypotension or hypertension within the past three months
19. Screening values which deviate 20% or more from the limits of normal which are considered to be clinically significant by the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modified Rodnan Skin Score at 0, 6 and 26 weeks.

Secondary Outcome Measures

Name	Time	Method
The following will be assessed at 0, 6 and 26 weeks:<br>1. Scleroderma Health Assessment Questionnaire <br>2. Scleroderma UK functional score <br>3. Patient and Physician Global Assessment <br>4. SF-36 Health Survey <br>5. Medical Research Concil (MRC) Sum Score