NCT00627146

Brief Summary

Compared to placebo, treatment with ChAgly CD3 has a beneficial effect on preservation of beta cell function and metabolic outcome in type 1 diabetic patients with recent clinical onset of disease that persists until 48 months after administration. The investigators also hypothesize that in type 1 diabetic patients with recent clinical onset of disease compared to placebo, ChAgly CD3 will be safe and well tolerated between 18 and 48 months after administration, based on assessment of clinical and laboratory adverse events.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2000

Longer than P75 for phase_2

Geographic Reach
2 countries

5 active sites

Status
completed

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

Study Start

First participant enrolled

June 1, 2000

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 29, 2008

Completed
Last Updated

September 29, 2008

Status Verified

September 1, 2008

Enrollment Period

6.8 years

First QC Date

February 22, 2008

Last Update Submit

September 25, 2008

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus, type 1ChAgly CD3

Outcome Measures

Primary Outcomes (1)

  • The difference in change in daily insulin need between baseline and month 48, between placebo and ChAgly CD3 treated patients

    48 months

Study Arms (2)

B

PLACEBO COMPARATOR
Drug: Placebo

A

ACTIVE COMPARATOR

ChAgly CD3

Drug: ChAgly CD3

Interventions

ChAgly CD3DRUG

6 days treatment 8mg/d intravenous

A
PlaceboDRUG

6 days

B

Eligibility Criteria

Age12 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Subjects with Type 1 diabetes mellitus included in the phase II therapeutic trial with a humanized non-mitogenic CD3 monoclonal antibody (ChAgly CD3) at time of clinical diagnosis and who agree and are likely to comply with the investigator's instructions

You may not qualify if:

  • Any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risks to the patient
  • Use of illicit drugs or over consumption of alcohol (\> 3 beers/day)
  • Being legally incapacitated, having significant emotional problems at the time of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Universitair Ziekenhuis Antwerpen

Antwerp, Belgium

Location

Universitair Ziekenhuis and Diabetes Research Center - Brussels Free University-VUB

Brussels, 1090, Belgium

Location

Hopital Erasme

Brussels, Belgium

Location

Department of Endocrinology and Nephrology, UZ Gasthuisberg, Katholieke Universiteit Leuven -KUL

Leuven, 3000, Belgium

Location

Hopital Schwabbing

Munich, Germany

Location

Related Publications (2)

  • Keymeulen B, Vandemeulebroucke E, Ziegler AG, Mathieu C, Kaufman L, Hale G, Gorus F, Goldman M, Walter M, Candon S, Schandene L, Crenier L, De Block C, Seigneurin JM, De Pauw P, Pierard D, Weets I, Rebello P, Bird P, Berrie E, Frewin M, Waldmann H, Bach JF, Pipeleers D, Chatenoud L. Insulin needs after CD3-antibody therapy in new-onset type 1 diabetes. N Engl J Med. 2005 Jun 23;352(25):2598-608. doi: 10.1056/NEJMoa043980.

    PMID: 15972866BACKGROUND

  • Keymeulen B, Walter M, Mathieu C, Kaufman L, Gorus F, Hilbrands R, Vandemeulebroucke E, Van de Velde U, Crenier L, De Block C, Candon S, Waldmann H, Ziegler AG, Chatenoud L, Pipeleers D. Four-year metabolic outcome of a randomised controlled CD3-antibody trial in recent-onset type 1 diabetic patients depends on their age and baseline residual beta cell mass. Diabetologia. 2010 Apr;53(4):614-23. doi: 10.1007/s00125-009-1644-9. Epub 2010 Jan 14.

    PMID: 20225393DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

otelixizumab

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Bart Keymeulen, MD,PhD

    Universitair Ziekenhuis Brussel

    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
OTHER

Study Record Dates

First Submitted

February 22, 2008

First Posted

February 29, 2008

Study Start

June 1, 2000

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

September 29, 2008

Record last verified: 2008-09

Locations

DE(1)BE(4)