NCT00769028

Brief Summary

To study the safety and tolerability of a hyperimmune goat serum product (AIMSPRO) in the treatment of systemic sclerosis (SSc) through a period of 26 weeks of study participation. The secondary objective of the study is to assess the efficacy of AIMSPRO as a therapeutic agent for SSc using inter alia the SSc-HAQ questionnaire and the modified Rodnan skin score.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

August 18, 2011

Status Verified

August 1, 2011

Enrollment Period

2.2 years

First QC Date

October 7, 2008

Last Update Submit

August 16, 2011

Conditions

Systemic Sclerosis

Keywords

Systemic sclerosisDiffuse cutaneous systemic sclerosisSclerodermaBiologicalHyperimmune caprine serumGoat Serum

Outcome Measures

Primary Outcomes (1)

  • Modified Rodnan Skin Score

    Baseline, Week 6 and Week 26

Secondary Outcomes (5)

  • Scleroderma Health Assessment Questionnaire

    Baseline, Week 6 and Week 26

  • Scleroderma UK Functional Score

    Baseline, Week 6 and Week 26

  • Patient and Physician Global Assessment (VAS)

    Baseline, Week 6 and Week 26

  • SF-36 (Short form 36)

    Baseline, Week 6 and Week 26

  • MRC Sum Score

    Week 0, Week 6 and Week 26

Study Arms (2)

AIMSPRO

EXPERIMENTAL
Drug: Hyperimmune caprine serum

Placebo

PLACEBO COMPARATOR
Drug: Albumin

Interventions

Hyperimmune caprine serumDRUG

Subcutaneous injection of serum, 1ml twice weekly for 6 months

Also known as: Ceremben, Hyperimmune goat serum
AIMSPRO
AlbuminDRUG

Subcutaneous injection of albumin, 1ml twice weekly for 6 months

Also known as: Placebo
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Rheumatology and Connective Tissue Diseases, Lower Ground Floor, Royal Free Hospital NHS Trust, Hampstead

London, NW3 2QG, United Kingdom

Location

Related Publications (2)

  • Quillinan N, Clark KE, Youl B, Vernes J, McIntosh D, Haq S, Denton CP. Multiplex serum protein analysis reveals potential mechanisms and markers of response to hyperimmune caprine serum in systemic sclerosis. Arthritis Res Ther. 2017 Mar 7;19(1):45. doi: 10.1186/s13075-017-1252-x.

    PMID: 28270187DERIVED

  • 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 Jan;73(1):56-61. doi: 10.1136/annrheumdis-2013-203674. Epub 2013 Sep 25.

    PMID: 24067785DERIVED

MeSH Terms

Conditions

Scleroderma, SystemicScleroderma, Diffuse

Interventions

Albumins

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

ProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Christopher P Denton, PhD FRCP

    Royal Free Hospital NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 7, 2008

First Posted

October 8, 2008

Study Start

December 1, 2008

Primary Completion

February 1, 2011

Study Completion

September 1, 2011

Last Updated

August 18, 2011

Record last verified: 2011-08

Locations

GB(1)