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

Instituto Mexicano del Seguro Social

Status and phase: Completed; Phase 2; Phase 1

Conditions: Arthritis, Rheumatoid

Treatments: Drug: Subcutaneous polyvidone collagen; Other: saline solution

Study type: Interventional

Funder types: Other

Identifiers

NCT06656169

Polyvidone collagen effect

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with arthritic hand uni or bilateral
• Early rheumatoid arthritis (> or equal to 2 years of evolution with treatment and stable)
• Conventional treatment based on non-steroidal anti-inflammatory drugs (NSAIDs) alone for the disease without the use of biologic therapy or DMARDs.

Exclusion criteria

• Patient with previous treatment of the arthritic hand with steroids, previous surgery and/or some other local medical treatment
• Persistence of symptoms and functional alterations.
• Patients with diabetes mellitus, rheumatic polyarthropathy, scleroderma, fibromyalgia, systemic lupus erythematosus or any other autoimmune disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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25 participants in 2 patient groups, including a placebo group

Case group

Experimental group

Description:

Patients with unilateral or bilateral arthritic hand, both genders, age of 60 years or older in treatment with subcutaneous polyvidone collagen.

Treatment:

Drug: Subcutaneous polyvidone collagen

Control group

Placebo Comparator group

Description:

Patients with unilateral or bilateral arthritic hand, both genders, age of 60 years or older

Treatment:

Other: saline solution