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

MacroGenics

Status: Terminated

Conditions: Type 1 Diabetes Mellitus

Treatments: Diagnostic Test: Blood samples for safety; Diagnostic Test: Analysis of T-cell subsets; Behavioral: Patient reported outcome questionnaires

Study type: Interventional

Funder types: Industry

Identifiers

NCT00870818

CP-MGA031-02

Details and patient eligibility

About

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).

Full 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.

Enrollment: 219 patients

Sex: All

Ages: 10 to 37 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

None

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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219 participants in 5 patient groups, including a placebo group

Double-blind Herold Regimen

Experimental group

Description:

Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.

Treatment:

Behavioral: Patient reported outcome questionnaires

Diagnostic Test: Analysis of T-cell subsets

Diagnostic Test: Blood samples for safety

Double-blind 33.3% Herold Regimen

Experimental group

Description:

Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.

Treatment:

Behavioral: Patient reported outcome questionnaires

Diagnostic Test: Analysis of T-cell subsets

Diagnostic Test: Blood samples for safety

Double-blind Curtailed Herold Regimen

Experimental group

Description:

Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.

Treatment:

Behavioral: Patient reported outcome questionnaires

Diagnostic Test: Analysis of T-cell subsets

Diagnostic Test: Blood samples for safety

Double-blind Placebo

Placebo Comparator group

Description:

Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.

Treatment:

Behavioral: Patient reported outcome questionnaires

Diagnostic Test: Analysis of T-cell subsets

Diagnostic Test: Blood samples for safety

Open-label Herold Regimen

Experimental group

Description:

Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.

Treatment:

Behavioral: Patient reported outcome questionnaires

Diagnostic Test: Analysis of T-cell subsets

Diagnostic Test: Blood samples for safety