Clinical trial NCT00870818: Protege Extension Trial - Long Term Follow Up Trial for Subjects Who Completed the Protege Study (CP-MGA031-01)
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: Teplizumab
Protege
MGA031
Monoclonal antibody
Type 1 Diabetes Mellitus
T1DM
MacroGenics
Lead sponsor: MacroGenics
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2009-03-27
Enrollment: 219
Sex: ALL
Minimum age (years): 10
Maximum age (years): 37
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Number of Participants Who Experience an Adverse Event, Serious Adverse Event or Adverse Event of Special Interest.
timeFrame: Duration of study participation up to 15 months
Secondary outcomes:
measure: Proportion of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%.
timeFrame: Month 6
measure: Proportion of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%.
timeFrame: Month 12
measure: Proportion of Subjects With HbA1c <6.5%
timeFrame: Month 6
measure: Mean HbA1c at 6 Months
timeFrame: 6 months
measure: Mean HbA1c at 12 Months
timeFrame: Month 12
measure: C-peptide Area Under the Curve (AUC) at 6 Months
timeFrame: Month 6
measure: C-peptide AUC at 12 Months
timeFrame: Month 12
measure: Total Daily Insulin Usage at 6 Months
timeFrame: Month 6
measure: Total Daily Insulin Usage at 12 Months
timeFrame: Month 12
measure: Mean Values for Participant-reported Outcomes on the 5-dimension European Quality of Life Questionnaire. (EQ-5D)
timeFrame: Month 6
measure: Mean Values for Participant-reported Outcomes on the EQ-5D
timeFrame: Month 12
measure: Pediatric Quality of Life Questionnaire Total Score
timeFrame: Month 6
measure: Pediatric Quality of Life Questionnaire Total Score
timeFrame: Month 12
measure: Percentage of Cells by Immunophenotype
timeFrame: Month 6
measure: Human Anti-human Antibody (HAHA) Levels
timeFrame: Month 6 and 12
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
Study officials:
References: