Protege Extension Trial - Long Term Follow Up Trial for Subjects Who Completed the Protege Study (CP-MGA031-01)
This study has been terminated.
Sponsor:
MacroGenics
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
MacroGenics
ClinicalTrials.gov Identifier:
NCT00870818
First received: March 26, 2009
Last updated: March 5, 2012
Last verified: March 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Type 1 Diabetes Mellitus |
Drug: Teplizumab |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by MacroGenics:
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. [ Time Frame: Duration of the study- 3 years ] [ Designated as safety issue: Yes ]
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. [ Time Frame: Month 6, 12, 18, 24, 30, 36 ] [ Designated as safety issue: No ]
- 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. [ Time Frame: Month 6, 12, 18, 24, 30, 36 ] [ Designated as safety issue: No ]
- Immunophenotyping of blood mononuclear cells will be summarized by visit and graphed over time, as appropriate. [ Time Frame: Month 6, 12, 18, 24, 30, 36 ] [ Designated as safety issue: No ]
- A secondary efficacy endpoint will be assessing Heath Related Quality of Life Questionnaires filled out by subjects at different timepoints in the study. [ Time Frame: Month 6, 12, 18, 24, 30, 36 ] [ Designated as safety issue: No ]
| Enrollment: | 219 |
| Study Start Date: | February 2009 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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| Ages Eligible for Study: | 10 Years to 37 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Exclusion Criteria:
None
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00870818
Locations
| United States, Georgia | |
| Atlanta Diabetes Associates | |
| Atlanta, Georgia, United States, 30309 | |
Sponsors and Collaborators
MacroGenics
Eli Lilly and Company
Investigators
| Study Director: | Anastasia G Daifotis, MD | MacroGenics |
More Information
Additional Information:
No publications provided
| Responsible Party: | MacroGenics |
| ClinicalTrials.gov Identifier: | NCT00870818 History of Changes |
| Other Study ID Numbers: | CP-MGA031-02 |
| Study First Received: | March 26, 2009 |
| Last Updated: | March 5, 2012 |
| Health Authority: | Canada: Health Canada Czech Republic: State Institute for Drug Control Estonia: The State Agency of Medicine Germany: Paul-Ehrlich-Institut India: Drugs Controller General of India Israel: Israeli Health Ministry Pharmaceutical Administration Latvia: State Agency of Medicines Mexico: Federal Commission for Sanitary Risks Protection Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Romania: Ministry of Public Health Spain: Spanish Agency of Medicines Sweden: Medical Products Agency Ukraine: Ministry of Health United States: Food and Drug Administration |
Keywords provided by MacroGenics:
|
Teplizumab Protege MGA031 Monoclonal antibody |
Type 1 Diabetes Mellitus T1DM MacroGenics |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases |
Immune System Diseases Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013