Condition category
Musculoskeletal Diseases
Date applied
07/10/2008
Date assigned
24/10/2008
Last edited
27/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Christopher Denton

ORCID ID

Contact details

Centre for Rheumatology and Connective Tissue Diseases
Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom
+44 (0)20 7317 7544
niamhq@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00769028

Protocol/serial number

DISS01

Study information

Scientific title

Acronym

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.

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

This study was approved by the National Research Ethics Committee, Royal Free Hospital NHS Trust on 30/07/2008 (ref: 08/H0720/63).

Study design

Treatment, parallel-assignment, double-blind (subject, caregiver, investigator, outcomes assessor), randomised, placebo-controlled, safety/efficacy trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

AIMSPRO®

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

21/10/2008

Overall trial end date

01/08/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant 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

Recruitment start date

21/10/2008

Recruitment end date

01/08/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Rheumatology and Connective Tissue Diseases
London
NW3 2QG
United Kingdom

Sponsor information

Organisation

Daval International Ltd (UK)

Sponsor details

4a Gildredge Street
Eastbourne
BN21 4RL
United Kingdom
+44 (0)845 130 3014
bryanyoul@gmail.com

Sponsor type

Industry

Website

http://www.davalinternational.com

Funders

Funder type

Industry

Funder name

Daval International Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24067785

Publication citations

  1. Results

    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, 73, 1, 56-61, doi: 10.1136/annrheumdis-2013-203674.

Additional files

Editorial Notes