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

Phase 1

• Conditions: 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 10039710 Term: Scleroderma; MedDRA version: 9.1 Level: LLT Classification code 10042954 Term: Systemic sclerosis pulmonary; MedDRA version: 9.1 Level: LLT Classification code 10036814 Term: Progressive systemic sclerosis; MedDRA version: 9.1 Level: LLT Classification code 10012941 Term: Diffuse scleroderma; MedDRA version: 9.1 Level: LLT Classification code 10018124 Term: Generalized scleroderma

• Registration Number: EUCTR2007-003122-24-GB
• Lead Sponsor: Daval International Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-02-15
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 20

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:
Haemoglobin8.5 g/dL
WBC3.5 x 109/L
Neutrophils1.5 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified