AIMSPRO in Established Diffuse Cutaneous Systemic Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00769028
• Date of registration: 07/10/2008
• Prospective Registration: Yes
• Primary sponsor: Daval International Limited
• Public title: AIMSPRO in Established Diffuse Cutaneous Systemic Sclerosis
• Scientific title: A Double-Blind Placebo-Controlled Pilot Study of Safety and Tolerability of AIMSPRO in Established Diffuse Cutaneous Systemic Sclerosis
• Date of first enrolment: December 2008
• Target sample size: 20
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00769028
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United Kingdom

Contacts

• Name: Christopher P Denton, PhD FRCP
• Affiliation: Royal Free Hospital NHS Trust

Key inclusion & exclusion criteria

Inclusion Criteria:

- Must fulfill 1980 Preliminary Classification Criteria for systemic sclerosis of the
American Rheumatism Association

- Diffuse cutaneous SSc, as evidenced by skin sclerosis proximal to the elbows or knees
and absence of the anti-centromere autoantibody

- At least three years must have elapsed since the 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.

- Screening laboratory test results:

Hemoglobin > 8.5 g/dL WBC > 3.5 x 10^9/L Neutrophils > 1.5 x 10^9/L Platelets > 100 x
10^9/L SGOT (AST) and alkaline phosphatase levels must be within twice the upper limit of
normal range for the laboratory conducting the test.

- Patient must be able to adhere to the study visit schedule and other protocol
requirements

- Patient must be capable of giving informed consent and the consent must be obtained
prior to any screening procedures

- No radiological evidence of malignancy, infection or (previous) tuberculosis in a
chest radiograph performed within three months prior to the first injection of study
drug

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 of study
drug).

- Use of any investigational drug within one month prior to screening or within five
half-lives of the investigational agent, whichever is longer.

- Use of a putative disease modifying drug (potential immunosuppressive drug) within
one month of screening.

- 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
[colds] or simple urinary tract infection) should be monitored to their conclusion or
treated, as appropriate, prior to inclusion.

- Active hepatitis-B or hepatitis-C.

- Active tuberculosis.

- Patients with 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.

- 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.

- Known recent substance abuse (drug or alcohol).

- Poor tolerability of venepuncture or lack of adequate venous access for required
blood sampling during the study period.

- Presence of a transplanted organ (with the exception of a corneal transplant > three
months prior to screening).

- Patients receiving immunosuppressive therapy within one month of screening.

- Patients with malignancy within the past five years.

- Signs or symptoms of severe, progressive or uncontrolled renal, hepatic,
haematologic, gastrointestinal, endocrine, pulmonary, cardiac or neurological disease
(including demyelinating diseases such as multiple sclerosis).

- Patients who, within the past three months, have had either a myocardial infarction,
uncontrolled congestive cardiac failure, unstable angina, uncontrolled systemic
hypotension or uncontrolled systemic hypertension.

- Patients who have screening laboratory values which deviate 20% or more from the
upper or lower limits of normal or which are considered to be clinically significant
to the investigator.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Systemic Sclerosis

Intervention(s)

Drug: Albumin

Drug: Hyperimmune caprine serum

Primary Outcome(s)

Modified Rodnan Skin Score [Time Frame: Baseline, Week 6 and Week 26]

Secondary Outcome(s)

Scleroderma Health Assessment Questionnaire [Time Frame: Baseline, Week 6 and Week 26]

Scleroderma UK Functional Score [Time Frame: Baseline, Week 6 and Week 26]

MRC Sum Score [Time Frame: Week 0, Week 6 and Week 26]

SF-36 (Short form 36) [Time Frame: Baseline, Week 6 and Week 26]

Patient and Physician Global Assessment (VAS) [Time Frame: Baseline, Week 6 and Week 26]

Secondary ID(s)

DISS01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors