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Tracking Information | |||||||||||||||||||||||||
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First Received Date † | December 12, 2006 | ||||||||||||||||||||||||
Last Updated Date | February 19, 2009 | ||||||||||||||||||||||||
Start Date † | December 2006 | ||||||||||||||||||||||||
Current Primary Outcome Measures † |
Adverse events, safety, laboratory parameters, vital signs, ECG and physical exam results. Disease parameters (neurologic exam, EDSS, 25 foot timed walk, 9-hole PEG test, MRI). Antibodies to drug. [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ] | ||||||||||||||||||||||||
Original Primary Outcome Measures † | Same as current | ||||||||||||||||||||||||
Change History | Complete list of historical versions of study NCT00411723 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||
Current Secondary Outcome Measures † | |||||||||||||||||||||||||
Original Secondary Outcome Measures † | |||||||||||||||||||||||||
Descriptive Information | |||||||||||||||||||||||||
Brief Title † | Safety Study of RTL1000 (Recombinant T Cell Receptor Ligand) in Subjects With Multiple Sclerosis | ||||||||||||||||||||||||
Official Title † | Phase 1 Safety Study of RTL1000 (Recombinant T Cell Receptor Ligand) in Subjects With Multiple Sclerosis | ||||||||||||||||||||||||
Brief Summary | RTL1000 is a new agent that has not been previously tested in humans. It is thought that RTL may specifically control the abnormal immune response or attack against the insulation on the nerves that occurs in multiple sclerosis. The purpose of this study is to evaluate the possible side effects of a single intravenous dose of RTL1000 in subjects with multiple sclerosis. Some subjects will also be asked to participate in one or both of two substudies, one to test blood samples to see how the body's immune system responds after administration of RTL1000, and the other to test blood samples to see how the body absorbs and eliminates the RTL1000. |
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Detailed Description | This is a double-blind, placebo-controlled treatment protocol with up to six treatment cohorts, each of which receives a single intravenous infusion of an escalating dose of RTL1000. Each dosing group will have six subjects: two who will receive a single dose of placebo and four who will receive a single dose of RTL1000. Subjects are observed in the hospital during the infusion and for 24 hours afterward, and are then followed weekly for 28 days and at 1 and 2 months post-infusion to evaluate safety parameters. Objectives of the study are to evaluate the safety profile of a single dose of RTL1000 administered by intravenous infusion, to evaluate the pharmacokinetic profile of RTL1000 in a subset of subjects, and to evaluate the feasibility of assessing immunologic parameters in a subset of subjects. Endpoints include vital signs, electrocardiogram and physical examination results, adverse events, and serious adverse events and safety laboratory parameters (e.g., clinical chemistries and hematology values). Disease parameters, such as neurological findings, expanded disability status scale (EDSS), 25-ft timed walk, 9-hole peg test, and magnetic resonance imaging (MRI) will be measured to ensure that study treatment does not make disease worse. Subjects will also be tested at the beginning and end of the study for antibodies to the drug and its components. |
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Study Phase | Phase I | ||||||||||||||||||||||||
Study Type † | Interventional | ||||||||||||||||||||||||
Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety Study | ||||||||||||||||||||||||
Condition † |
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Intervention † |
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Study Arms / Comparison Groups | |||||||||||||||||||||||||
Publications * | |||||||||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||||||||||||||||||
Recruitment Status † | Active, not recruiting | ||||||||||||||||||||||||
Enrollment † | 34 | ||||||||||||||||||||||||
Estimated Completion Date | May 2009 | ||||||||||||||||||||||||
Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||
Eligibility Criteria † | A specific blood cell type called HLA-DR2 may be required in order for RTL1000 to work. For that reason, all subjects will be tested for HLA-DR2 and only those subjects who test positive (about 50%) will undergo further tests to determine if they meet inclusion and exclusion criteria. Inclusion criteria:
Exclusion Criteria:
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Gender | Both | ||||||||||||||||||||||||
Ages | 18 Years to 65 Years | ||||||||||||||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||||||||||||||
Contacts †† | |||||||||||||||||||||||||
Location Countries † | United States | ||||||||||||||||||||||||
Expanded Access Status | |||||||||||||||||||||||||
Administrative Information | |||||||||||||||||||||||||
NCT ID † | NCT00411723 | ||||||||||||||||||||||||
Responsible Party | Andrew S. Goldstein, Artielle ImmunoTherapeutics, Inc. | ||||||||||||||||||||||||
Secondary IDs †† | |||||||||||||||||||||||||
Study Sponsor † | Artielle ImmunoTherapeutics | ||||||||||||||||||||||||
Collaborators †† | |||||||||||||||||||||||||
Investigators † |
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Information Provided By | Artielle ImmunoTherapeutics | ||||||||||||||||||||||||
Verification Date | February 2009 | ||||||||||||||||||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |