Protege Extension Trial - Long Term Follow Up Trial for Subjects Who Completed the Protege Study (CP-MGA031-01)

Sponsor

MacroGenics (Industry)

Overall Status

Terminated

CT.gov ID

NCT00870818

Collaborator

Eli Lilly and Company (Industry)

219

Enrollment

Location

Arms

26.9

Duration (Months)

8.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the long term safety and efficacy in subjects with Type 1 Diabetes Mellitus who completed the Protege Study (CP-MGA031-01).

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes Mellitus	Drug: Teplizumab	Phase 2/Phase 3

Detailed Description

The primary objective of the extension study is to assess long-term safety, with particular focus on the development of serious adverse events (SAEs), adverse events of special interest (AESIs) including opportunistic infections and lymphoproliferative disease, and other immediately reportable events (IREs), in subjects with recent-onset T1DM who complete CP-MGA031-01.

The secondary objectives of the extension study are to: 1) assess long-term efficacy; 2) evaluate immunological effects(North America only); 3) measure anti-teplizumab antibody levels;4) assess Health Related Quality of Life Questionnaires.

Study Design

Study Type:

Interventional

Actual Enrollment :

219 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

An Extension of Study CP-MGA031-01 to Evaluate the Long-Term Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Patients With Recent-Onset Type 1 Diabetes Mellitus

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Feb 1, 2011

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Active Protege had 4 study arms, 3 were dosed with different doses of teplizumab, and 1 was a control group given placebo. This Extension study will continue to assess the subjects from these 4 arms. In Protege: Experimental Drug: Teplizumab, IV dosing daily for 14 days times 2 courses	Drug: Teplizumab No additional drug or placebo will be administered in this study. Blood will be drawn every 6 months after the last visit of the Protege Study for 3 years. Blood will be collected for chemistry, hematology, thyroid function, immunology, serology, autoantibodies, and metabolic function.
Experimental: 2 Active In Protege: Experimental Drug: Teplizumab, IV dosing daily for 14 days times 2 courses	Drug: Teplizumab No additional drug or placebo will be administered in this study. Blood will be drawn every 6 months after the last visit of the Protege Study for 3 years. Blood will be collected for chemistry, hematology, thyroid function, immunology, serology, autoantibodies, and metabolic function.
Experimental: 3 Active In Protege: Experimental Drug: Teplizumab, IV dosing daily for 14 days times 2 courses	Drug: Teplizumab No additional drug or placebo will be administered in this study. Blood will be drawn every 6 months after the last visit of the Protege Study for 3 years. Blood will be collected for chemistry, hematology, thyroid function, immunology, serology, autoantibodies, and metabolic function.
Placebo Comparator: 1 controlled In Protege: Placebo Comparator: IV dosing daily for 14 days times 2 courses	Drug: Teplizumab No additional drug or placebo will be administered in this study. Blood will be drawn every 6 months after the last visit of the Protege Study for 3 years. Blood will be collected for chemistry, hematology, thyroid function, immunology, serology, autoantibodies, and metabolic function.

Outcome Measures

Primary Outcome Measures

Primary outcome measures will include the number and percentage of subjects who experience a SAE, Adverse Event of Special Interest (including Opportunistic Infection, Lymphopoliferative disease), or other Immediately Reportable Event. [Duration of the study- 3 years]

Secondary Outcome Measures

A secondary endpoint will be determining the efficacy of teplizumab by measuring the subject's total daily insulin usage and HbA1c levels. [Month 6, 12, 18, 24, 30, 36]
C-peptide secretory response will be analyzed in terms of basal levels of C-peptide produced before a mixed meal and stimulated levels after a mixed meal, measured as AUC and peak post-meal production. [Month 6, 12, 18, 24, 30, 36]
Immunophenotyping of blood mononuclear cells will be summarized by visit and graphed over time, as appropriate. [Month 6, 12, 18, 24, 30, 36]
A secondary efficacy endpoint will be assessing Heath Related Quality of Life Questionnaires filled out by subjects at different timepoints in the study. [Month 6, 12, 18, 24, 30, 36]

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 37 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Complete Protocol CP-MGA031-01 (i.e., all subjects who complete Study Day 728, regardless of how many doses of study drug are received).
Provide written informed consent.