General information Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.
Scientific title:
Toxicological evaluation of the humanized Anti-CD6 MAb T1h in Rheumatoid Arthritis Patients. Clinical Trial phase I.
Secondary indentifying numbers:
Issuing authority of the secondary identifying numbers:
Center of Molecular Immunology (CIM)
Source(s) of monetary or material support:
Authorization for beginning Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.
Regulatory instance to authorize the initiation of the study:
Center for State Control of the Quality of Drugs(CECMED)
Principal investigator Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
First name:
Gil Alberto Reyes Llerena M.D., PhD.,2nd degree of specialist in Rheumatology
Clinical sites to participate Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.
Countries of recruitment:
Clinical sites:
Havana City, National Service of Rheumatology of Clinical and Surgical Teaching Hospital "10 de Octubre", Roberto Torres Moya, MD. 2nd degree specialist in Rheumatology
Research ethics committees:
Center of Researches Surgical-Medical (CIMEQ), October 18, 2002. Clinical and Surgical Teaching Hospital "10 de Octubre", February 2th, 2004.
Recruitment status Section to complete information about the recruitment status and the date of first enrolment subject
Date of first enrollment:
Health condition and Intervention Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).
Health condition(s) or Problem(s) studied:
Intervention(s):
Four level of dosis of humanized Anti-CD6 MAb T1h Level 1: 0.1 mg/Kg Level 2: 0.2 mg/Kg Level 3: 0.4 mg/Kg, and Level 4: 0.8 mg/Kg It begins in the lower level. Each patient receives a total of 6 administrations of MAb by intravenously route once a week for 6 weeks.
Outcomes and Timepoint Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Security of T1h in the maximum dose level, expressed as no incidence of severe adverse events, no immunogenicity and no signs of opportunistic infections. Expression of ACR20. Measuring Time: 1st and 4th weeks after the last dose of T1h.
Key secondary outcomes:
Expression of ACR50. Measuring Time: 1st and 4th weeks after the last dose of T1h.
Selection criterias Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.
Inclusion criteria:
1. Patients who expressed in writing in its informed consent form their willingness to participate in the clinical trial. 2. Age over 18 and under 70 annos annos, of either sex or race. 3. Patient who has not previously been treated with monoclonal antibodies. 4. Patients without concomitant anti-rheumatic during the four weeks before the administration of MAb and until 4 weeks after completing the administration of the last dose of mAb (only able to receive the paracetamol as a painkiller). 5. Patients with hemoglobin> 10 g / L, WBC> 3x109 cells / mL, platelet count> 100x109/mL and transaminase (GPT) within the normal reference values (UI).
Exclusion criteria:
1. Functional class IV according to Steinbrocker's criteria 2. Intercurrent infection. 3. Concomitant severe chronic disease (lung, heart, liver or kidney). 4. Pregnancy, childbirth and/or breastfeeding. 5. Female patients of childbearing age who do not have a negative pregnancy diagnosis and / or refuses to use an IUD as contraceptive method for as long as the extension of the study. 6. Patients who not meet the inclusion criteria. 7. Patients with history of severe allergies. 8. Patients with psychological dysfunction, intellectual or sensory impairment, that not allow to understand and compliance with study requirements according to criteria of the Principal Investigator. 9. Patients with any type of malignancy desease
Study design Section to complete information about the characteristics of the study design.
Contact for public queries Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status
Affiliation:
Center of Molecular Immunology (CIM)
Postal Address:
Calle 216 Esquina 15, Atabey, Playa
Contact for scientific queries Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.
Affiliation:
Center of Molecular Immunology (CIM)
Postal Address:
Calle 216 Esquina 15, Atabey, Playa
Registration and Update Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).
Date of Registration in Primary Registry:
Record Verification Date:
Link to the spanish version:
