NCT06656169

Effect of Subcutaneous Polyvidone Collagen Treatment on Hand Recovery in Adult Rheumatoid Arthritis.

Effect of Subcutaneous Polyvidone Collagen Treatment vs Placebo on Clinical Hand Recovery, Biochemical Response and Quality of Life in Adult Rheumatoid Arthritis.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Instituto Mexicano del Seguro Social · Other Government
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

A study in geriatric rheumatology on the treatment of rheumatoid arthritis (RA) in older adults is described. Its objective is to compare the effects of subcutaneous polyvidone collagen versus placebo, analyzing clinical improvement, biochemical response and quality of life in people over 60 years of age. The Phase IV, double-blind, randomized, placebo-controlled clinical trial will be conducted between 2023 and 2026. Sixty patients with early-stage arthritis will participate, assessing factors such as pain, functionality and synovitis with various statistical tools and analyses.

Detailed description

Geriatric rheumatology specializes in the study of rheumatic diseases in older adults, who have immune and physiological characteristics that influence the manifestation of these diseases. In the case of rheumatoid arthritis (RA), a chronic inflammatory disease that affects the joints, treatments that improve functionality and reduce pain in the hands, evaluated by ultrasound, are studied. Its objective is to compare the effects of treatment with subcutaneous polyvidone collagen versus placebo on clinical improvement of the hands, biochemical response and quality of life in people over 60 years of age with rheumatoid arthritis. A Phase IV, double-blind, randomized, placebo-controlled clinical trial will be conducted between August 2023 and August 2026. Sixty patients (30 in each group) with early-stage arthritis will participate. Pain, functionality, synovitis, and quality of life will be assessed using various scales, biochemical analyses, and statistical tests.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	Subcutaneous polyvidone collagen	Use collagen-polyvidone at a dose of 0.2 ml, applied to the affected area of the hand.
OTHER	saline solution	administer saline solution at a dose of 0.2 ml, applied to the affected area of the hand.

Timeline

• Start date: 2021-01-01
• Primary completion: 2023-01-06
• Completion: 2023-01-07
• First posted: 2024-10-24
• Last updated: 2025-05-01

Locations

2 sites across 1 country: Mexico

Regulatory

• FDA-regulated drug study