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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- MacroGenics
- 入组人数
- 219
- 试验地点
- 2
- 主要终点
- The Number of Participants Who Experience an Adverse Event, Serious Adverse Event or Adverse Event of Special Interest.
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 37 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
Open-label Herold Regimen
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.
干预措施: Patient reported outcome questionnaires (Behavioral)
Double-blind Curtailed Herold Regimen
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.
干预措施: Analysis of T-cell subsets (Diagnostic Test)
Double-blind Herold Regimen
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.
干预措施: Blood samples for safety (Diagnostic Test)
Double-blind Herold Regimen
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.
干预措施: Patient reported outcome questionnaires (Behavioral)
Double-blind Herold Regimen
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.
干预措施: Analysis of T-cell subsets (Diagnostic Test)
Double-blind 33.3% Herold Regimen
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.
干预措施: Blood samples for safety (Diagnostic Test)
Double-blind 33.3% Herold Regimen
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.
干预措施: Patient reported outcome questionnaires (Behavioral)
Double-blind 33.3% Herold Regimen
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.
干预措施: Analysis of T-cell subsets (Diagnostic Test)
Double-blind Curtailed Herold Regimen
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.
干预措施: Blood samples for safety (Diagnostic Test)
Double-blind Curtailed Herold Regimen
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.
干预措施: Patient reported outcome questionnaires (Behavioral)
Double-blind Placebo
Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
干预措施: Blood samples for safety (Diagnostic Test)
Double-blind Placebo
Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
干预措施: Patient reported outcome questionnaires (Behavioral)
Double-blind Placebo
Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
干预措施: Analysis of T-cell subsets (Diagnostic Test)
Open-label Herold Regimen
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.
干预措施: Blood samples for safety (Diagnostic Test)
Open-label Herold Regimen
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.
干预措施: Analysis of T-cell subsets (Diagnostic Test)
结局指标
主要结局
The Number of Participants Who Experience an Adverse Event, Serious Adverse Event or Adverse Event of Special Interest.
时间窗: Duration of study participation up to 15 months
次要结局
- Mean HbA1c at 12 Months(Month 12)
- C-peptide Area Under the Curve (AUC) at 6 Months(Month 6)
- Mean Values for Participant-reported Outcomes on the 5-dimension European Quality of Life Questionnaire. (EQ-5D)(Month 6)
- Pediatric Quality of Life Questionnaire Total Score(Month 12)
- 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%.(Month 12)
- Proportion of Subjects With HbA1c <6.5%(Month 6)
- Mean HbA1c at 6 Months(6 months)
- Mean Values for Participant-reported Outcomes on the EQ-5D(Month 12)
- Human Anti-human Antibody (HAHA) Levels(Month 6 and 12)
- C-peptide AUC at 12 Months(Month 12)
- Total Daily Insulin Usage at 6 Months(Month 6)
- Total Daily Insulin Usage at 12 Months(Month 12)
- Percentage of Cells by Immunophenotype(Month 6)