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

This study has been terminated.
Sponsor:
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
  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:

  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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014