Toxicological evaluation of the humanized Anti-CD6 MAb T1h in Rheumatoid Arthritis Patients

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000007
• Date of registration: 24/12/2010
• Primary sponsor: Center of Molecular Immunology (CIM)
• Public title: Toxicological evaluation of the humanized Anti-CD6 MAb T1h in Rheumatoid Arthritis Patients
• Scientific title: Toxicological evaluation of the humanized Anti-CD6 MAb T1h in Rheumatoid Arthritis Patients. Clinical Trial phase I.
• Date of first enrolment: 30/07/2004
• Target sample size: 19
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000007-En
• Study type: Interventional
• Study design: Randomization: N/A: single arm study. Blinding: Open. Placebo: Uncontrolled Assignment: Single Group Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Pedro Rodriguez
• Affiliation: Center of Molecular Immunology (CIM)

• Name: Pedro Rodriguez
• Affiliation: Center of Molecular Immunology (CIM)

Key inclusion & exclusion criteria

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

Age minimum: 18 years
Age maximum: 69 years
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Four level of dosis of humanized Anti-CD6 MAb T1h Level 1: 0.2 mg/Kg Level 2: 0.4 mg/Kg Level 3: 0.8 mg/Kg, and Level 4: 1.6 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.

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.

Secondary Outcome(s)

Expression of ACR50. Measuring Time: 1st and 4th weeks after the last dose of T1h.

Secondary ID(s)

IIC RD-063

Source(s) of Monetary Support

Government funds

Secondary Sponsor(s)

Not applicable