Phase I with CIGB-814 in rheumatoid arthritis patients

Phase 1

Completed

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

• Registration Number: RPCEC00000238
• Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB), in Havana

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. Patients diagnosed of rheumatoid arthritis active = 2 years
2. Patients with moderate disease activity (DAS28)
3. Patients that did not respond to conventional treatment
4. Patients evaluated in ex vivo assays with CIGB-814
5. 19 = Age < 65
6. Laboratory parameters within normal limits
7. Female patient of gestation age with negative pregnancy test and use effective contraceptive methods or male patient employing effective methods to prevent procreation.
8. Patient complimenting a previous period of washing, which ranged from 2 to 4 weeks, according to previous treatment with or without FARME
9. Personal interest express written by the patient enrolled in the study with his/her signature consent to participate.

Exclusion Criteria

1. Pregnancy, postpartum or breastfeeding.
2. Allergy to paracetamol.
3. Treatment with another investigational product at the time of inclusion.
4. Rheumatoid arthritis burned.
5. Complicated Rheumatoid arthritis
6. Other rheumatic autoimmune diseases affecting the osteomioarticular system.
7. Alcoholism.
8. Patient drug-dependent.
9. Concomitant Chronic Diseases
10. States due to severe febrile infectious or septic processes not associated with disease progression.
11. Hematologic disease.
12. Malignancy.
13. Congenital or acquired immune deficiency at the time of inclusion.
14. Psychological intellectual or sensory dysfunction that may impede understanding and compliance with the requirements of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severe Adverse Events (EA) with very probable / certain or probable causal relationship with product administration (serious / serious seriousness with probable, very likely / safe causation). Measurement time: weekly (1st month) and months 2, 3, 4, 5, 6, 9 and 12.