A double-blind placebo-controlled pilot study of safety and tolerability of AIMSPRO® in established diffuse cutaneous systemic sclerosis
| ISRCTN | ISRCTN54813778 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54813778 |
| ClinicalTrials.gov (NCT) | NCT00769028 |
| Protocol serial number | DISS01 |
| Sponsor | Daval International Ltd (UK) |
| Funder | Daval International Ltd (UK) |
- Submission date
- 07/10/2008
- Registration date
- 24/10/2008
- Last edited
- 27/09/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Christopher Denton
Scientific
Scientific
Centre for Rheumatology and Connective Tissue Diseases
Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom
| Phone | +44 (0)20 7317 7544 |
|---|---|
| niamhq@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Treatment, parallel-assignment, double-blind (subject, caregiver, investigator, outcomes assessor), randomised, placebo-controlled, safety/efficacy trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | That the hyperimmune caprine serum medication AIMSPRO® will be a safe and well tolerated therapy for patients with established diffuse cutaneous systemic sclerosis. As of 18/08/2011 the anticipated end date of this trial has been refined, and the following end dates are now accurate: Double-blind phase end date: September 2011 Open-label phase end date: October 2011 |
| Ethics approval(s) | This study was approved by the National Research Ethics Committee, Royal Free Hospital NHS Trust on 30/07/2008 (ref: 08/H0720/63). |
| Health condition(s) or problem(s) studied | Diffuse cutaneous systemic sclerosis |
| Intervention | AIMSPRO® (manufactured by Sypharma Pty Ltd, Australia) 1.0 ml twice weekly for 6 months, injected sub-cutaneously vs placebo. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | AIMSPRO® |
| Primary outcome measure(s) |
Modified Rodnan Skin Score at 0, 6 and 26 weeks. |
| Key secondary outcome measure(s) |
The following will be assessed at 0, 6 and 26 weeks: |
| Completion date | 01/08/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 20 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 21/10/2008 |
| Date of final enrolment | 01/08/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Centre for Rheumatology and Connective Tissue Diseases
London
NW3 2QG
United Kingdom
NW3 2QG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2014 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
