Evaluation of Safety and Efficacy of T1h (anti-CD6) as Monotherapy and in Combination with Methotrexate in Patientes with Rheumatoid Arthritis

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000035
• Date of registration: 27/12/2010
• Primary sponsor: Center of Molecular Immunology (CIM)
• Public title: Evaluation of Safety and Efficacy of T1h (anti-CD6) as Monotherapy and in Combination with Methotrexate in Patientes with Rheumatoid Arthritis
• Scientific title: Evaluation of Safety and Efficacy of T1h (anti-CD6) as Monotherapy and in Combination with Methotrexate in Patientes with Rheumatoid Arthritis
• Date of first enrolment: 14/01/2008
• Target sample size: 40 (20 in each step)
• Recruitment status: Active
• URL: http://registroclinico.sld.cu/trials/RPCEC00000035-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Placebo Assignment: Other Purpose: Treatment Other design features: Phase I/II in two sequential steps: Step I: Multi-dose Ranging study. Step II: Randomized, Placebo-controlled, Double blind, Two arms, Parallel group study.

Countries of recruitment

Cuba

Contacts

• Name: Patricia Hernandez Casana
• Affiliation: Center of Molecular Immunology (CIM)

• Name: Patricia Hernandez Casanna
• Affiliation: Center of Molecular Immunology (CIM)

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients who expressed in writing in its informed consent form available from participating in the clinical trial. 2. Age between 18 and 65, inclusive, of any gender or skin color. 3. Patient who has not previously been treated with monoclonal antibodies. 4. Patients with at least 1 year with active RA diagnosed according to ACR criteria (American College of Rheumatology) revised in 1987. 5. Patients without concomitant anti-rheumatic during the four weeks before the administration of MAb. 6. Patients with hemoglobin = 8.5 g / L, WBC> 3x109 cells / mL, platelet count> 100x109/mL and transaminase (TGP) within the normal reference values (UI). 7. Patients with 8 or more joints swollen at the time of starting treatment. 8. Patients with 8 or more joints painful at the time of starting treatment.
Exclusion criteria: 1. Suffering from severe chronic concomitant Central Nervous System, Respiratory, cardiovascular, gastrointestinal tract or genitourinary system. 2. Suffering from any malignancy. 3. Suffering from an acute infection at the time of inclusion. 4. Suffering from a chronic infection. 5. Any Hematopoietic system disorder (congenital or acquired). 6. Suffering from other autoimmune rheumatic diseases that affect osteomioarticular system. 7. Pregnancy, childbirth and / or breastfeeding. 8. Patients who refuse to use contraception during the study. 9. Patients with intellectual or psychological dysfunction that not allow to understand and compliance with study requirements, according to the Principal Investigator.

Age minimum: 18 years
Age maximum: 65 years
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Stage I: Four level doses of T1h (0.1, 0.2, 0.4 y 0.8 mg/Kg respectively) by Intravenous route [IV] (infusion in 200 mL of sterile 0.9% sodium chloride solution over 2 hours) once weekly for 12 weeks. Stage II: Group control: Placebo Group study: T1h at optimal dose determined in Stage I Both groups will receive the product (placebo or T1h) by intravenous route (detailed above), once weekly for 12 weeks. All patients will also receive concomitant MTX (7.5 to 25 mg/Kg orally), once weekly for 12 weeks.

Primary Outcome(s)

Safety, tolerability and optimal biological dose. Measuring time: 6 months.

Secondary Outcome(s)

To evaluate dose ranging PKs, ACR20, ACR50. Measuring time: 6 months.

Secondary ID(s)

IIC RD-EC098

Source(s) of Monetary Support

Government Funds

Secondary Sponsor(s)

No applicable