Clinical trial NCT06656169: Effect of Subcutaneous Polyvidone Collagen Treatment on Hand Recovery in Adult Rheumatoid Arthritis.
Official title: Effect of Subcutaneous Polyvidone Collagen Treatment vs Placebo on Clinical Hand Recovery, Biochemical Response and Quality of Life in Adult Rheumatoid Arthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Arthritis, Rheumatoid
Keywords: Rheumatoid Arthritis
Collagen Polyvidone
Synovial Tissue
Tumor necrosis factor-alpha
American College of Rheumatology Questionnaire
Rheumatoid Factor
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2024-10-24
Enrollment: 25
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A double-blind, randomized, masked, placebo-controlled, randomized clinical trial will be conducted
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effect of subcutaneous polyvidone collagen treatment on clinical hand recovery in adults with rheumatoid arthritis using the modified Kapandji Index, pain scale, and hand pressure strength.
timeFrame: Every 15 days for 2 months
Secondary outcomes:
measure: Effect of subcutaneous polyvidone collagen treatment in quality of life in adult rheumatoid arthritis
timeFrame: 2 months
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: National Western Speciality Hospital, Mexican Social Security Institute
state: Jalisco
city: Guadalajara
country: Mexico
facility: Unidad de Investigación Biomédica 02, Unidad Médica de alta especialidad, Hospital de Especialidades Centro Médico Nacional de Occidente, Instituto Mexicano del Seguro Social, Guadalajara 44329, México
state: Jalisco
Study officials:
affiliation: IMSS
name: Clotilde Fuentes, 1
role: PRINCIPAL_INVESTIGATOR
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