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

March 26, 2009
March 5, 2012
February 2009
February 2011   (final data collection date for primary outcome measure)
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 ]
Primary outcome measures will include the number and percentage of subjects who experience an 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 ]
Complete list of historical versions of study NCT00870818 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Protege Extension Trial - Long Term Follow Up Trial for Subjects Who Completed the Protege Study (CP-MGA031-01)
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

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).

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 1 Diabetes Mellitus
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: 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

    Intervention: Drug: Teplizumab
  • Experimental: 2 Active
    In Protege: Experimental Drug: Teplizumab, IV dosing daily for 14 days times 2 courses
    Intervention: Drug: Teplizumab
  • Experimental: 3 Active
    In Protege: Experimental Drug: Teplizumab, IV dosing daily for 14 days times 2 courses
    Intervention: Drug: Teplizumab
  • Placebo Comparator: 1 controlled
    In Protege: Placebo Comparator: IV dosing daily for 14 days times 2 courses
    Intervention: Drug: Teplizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
219
May 2011
February 2011   (final data collection date for primary outcome measure)

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

Both
10 Years to 37 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00870818
CP-MGA031-02
No
MacroGenics
MacroGenics
Eli Lilly and Company
Study Director: Anastasia G Daifotis, MD MacroGenics
MacroGenics
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP