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30 July 2010
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| [ Print-friendly version ] |
| A double-blind placebo-controlled pilot study of safety and tolerability of AIMSPRO® in established diffuse cutaneous systemic sclerosis |
| ISRCTN | ISRCTN54813778 |
| ClinicalTrials.gov identifier | |
| Public title | A double-blind placebo-controlled pilot study of safety and tolerability of AIMSPRO® in established diffuse cutaneous systemic sclerosis |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | DISS01 |
| Study hypothesis | That the hyperimmune caprine serum medication AIMSPRO® will be a safe and well tolerated therapy for patients with established diffuse cutaneous systemic sclerosis. |
| Ethics approval | This study was approved by the National Research Ethics Committee, Royal Free Hospital NHS Trust on 30 July 2008 (ref: 08/H0720/63). |
| Study design | Treatment, parallel-assignment, double-blind (subject, caregiver, investigator, outcomes assessor), randomised, placebo-controlled, safety/efficacy trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Diffuse cutaneous systemic sclerosis |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 21/10/2008 |
| Anticipated end date | 21/10/2009 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 20 |
| Interventions | AIMSPRO® (manufactured by Sypharma Pty Ltd, Australia) 1.0 ml twice weekly for 6 months, injected sub-cutaneously vs placebo. |
| Primary outcome measure(s) | Modified Rodnan Skin Score at 0, 6 and 26 weeks. |
| Secondary outcome measure(s) |
The following will be assessed at 0, 6 and 26 weeks:
1. Scleroderma Health Assessment Questionnaire 2. Scleroderma UK functional score 3. Patient and Physician Global Assessment 4. SF-36 Health Survey 5. Medical Research Concil (MRC) Sum Score |
| Sources of funding | Daval International Ltd (UK) |
| Trial website | |
| Publications | |
| Contact name | Prof Christopher Denton |
| Address |
Centre for Rheumatology and Connective Tissue Diseases
Royal Free Hospital Pond Street |
| City/town | London |
| Zip/Postcode | NW3 2QG |
| Country | United Kingdom |
| Tel | +44 (0)20 7317 7544 |
| niamhq@gmail.com | |
| Sponsor | Daval International Ltd (UK) |
| Address | 4a Gildredge Street |
| City/town | Eastbourne |
| Zip/Postcode | BN21 4RL |
| Country | United Kingdom |
| Tel | +44 (0)845 130 3014 |
| Fax | +44 (0)845 603 1190 |
| bryanyoul@gmail.com | |
| Sponsor website: | http://www.davalinternational.com |
| Date applied | 07/10/2008 |
| Last edited | 24/10/2008 |
| Date ISRCTN assigned | 24/10/2008 |
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| © 2010 ISRCTN unless otherwise stated. | |
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