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

Phase 1

Suspended

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

• Registration Number: RPCEC00000035
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stage I: Safety, tolerability and optimal biological dose. Measuring time: 4th week after last T1h dose.<br><br>Stage II: ACR50. Measuring time: 12nd week after last T1h dose.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics, ACR20, ACR50, ACR 70. Measuring time: during 24 weeks of study<br>