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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	25 November 2019
Main ID:	EUCTR2007-003122-24-GB
Date of registration:	15/02/2008
Prospective Registration:	Yes
Primary sponsor:	Daval International Limited
Public title:	A Double-Blind Placebo-Controlled Pilot Study of the Safety and Tolerability of AIMSPRO in established Diffuse Cutaneous Systemic Sclerosis - Pilot study of AIMSPRO in diffuse cutaneous systemic sclerosis
Scientific title:	A Double-Blind Placebo-Controlled Pilot Study of the Safety and Tolerability of AIMSPRO in established Diffuse Cutaneous Systemic Sclerosis - Pilot study of AIMSPRO in diffuse cutaneous systemic sclerosis
Date of first enrolment:	09/04/2008
Target sample size:	20
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-003122-24
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
Phase:	Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment
United Kingdom

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
Men and women over 18 years of age.
Diffuse cutaneous scleroderma (according to the 1980 ACR crtieria) with greater than three years since first non-Raynaud's manifestation.
Men and women of childbearing 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®.
The screening laboratory test results must meet the following minimum criteria:
Haemoglobin 8.5 g/dL
WBC 3.5 x 109/L
Neutrophils 1.5 x 109/L
Platelets 100 x 109/L
AST and alkaline phosphatase levels must be greater than 2 x ULN for the laboratory conducting the test.
Able to adhere to the study visit schedule and other protocol requirements.
Able voluntarily to give written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Women who are pregnant, nursing, or planning pregnancy within one and a half years after screening (i.e., approximately six months following last injection)
Use of any investigational drug within one month prior to screening or within five half-lives of the investigational agent, whichever is longer.
Treatment with any therapeutic agent targeted at reducing TNF (e.g., infliximab, pentoxifylline, thalidomide, etanercept, etc.) within three months of screening.
Previous administration of AIMSPRO.
History of known allergy to animal proteins.
Serious infections such as pneumonia or pyelonephritis in the previous three months. Less serious infections such as acute upper respiratory tract infection (cold) or simple urinary tract infection should be followed to their conclusion or treated, as appropriate, prior to inclusion.
Opportunistic infections including, but not limited to, evidence of active cytomegalovirus, active Pneumocystis carinii, Aspergillosis, histoplasmosis or atypical mycobacterium infection, etc, within the previous six months.
Active tuberculosis.
Presence of a transplanted organ (with the exception of a corneal transplant > three months prior to screening).
History of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infra-clavicular, epitrochlear, or periaortic areas), or splenomegaly.
Poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period.
Malignancy within the last 5 years.
Severe, progressive or uncontrolled renal, hepatic, haematologic, gastrointestinal, endocrine, pulmonary, cardiac or neurological disease.
Myocardial infarction, uncontrolled congestive cardiac failure, unstable angina, hypotension or hypertension within the past three months.

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Diffuse Cutaneous Systemic Sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10012977 Term: Diffuse systemic sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10036814 Term: Progressive systemic sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10039710 Term: Scleroderma
MedDRA version: 9.1 Level: LLT Classification code 10012941 Term: Diffuse scleroderma
MedDRA version: 9.1 Level: LLT Classification code 10018124 Term: Generalized scleroderma
MedDRA version: 9.1 Level: LLT Classification code 10042954 Term: Systemic sclerosis pulmonary

Intervention(s)

Product Name: AIMSPRO
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Secondary Objective: To assess the efficacy of AIMSPRO as a therapeutic agent for systemic sclerosis.

Main Objective: To assess the safety and tolerability of AIMSPRO in established Diffuse Cutaneous Systemic Sclerosis.

Primary end point(s): Safety and tolerability of AIMSPRO are the primary objectives of this study. No primary efficacy measures will be assessed or analysed.

Secondary Outcome(s)

Secondary ID(s)

DISS01

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date:
Contact:

Results

Results available:
Date Posted:
Date Completed:
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