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

Phase 1

Conditions: Rheumatoid Arthritis
Arthritis, Rheumatoid
Arthritis
Rheumatic Diseases
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Autoimmune Diseases
Autoimmune System Diseases

Registration Number: RPCEC00000007

Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 15

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

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures