Arthritis, Rheumatoid
Conditions
Keywords
Rheumatoid Arthritis, Collagen Polyvidone, Synovial Tissue, Tumor necrosis factor-alpha, American College of Rheumatology Questionnaire, Rheumatoid Factor
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.
Interventions
DRUGSubcutaneous polyvidone collagen
Use collagen-polyvidone at a dose of 0.2 ml, applied to the affected area of the hand.
OTHERsaline solution
administer saline solution at a dose of 0.2 ml, applied to the affected area of the hand.
Sponsors
Instituto Mexicano del Seguro Social
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A double-blind, randomized, masked, placebo-controlled, randomized clinical trial will be conducted
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Every 15 days for 2 months | The clinical recovery of the hand in adults with rheumatoid arthritis will be evaluated by means of a modified Kapandji index, which consists of a test that allows evaluating the result of three different functions of the hand; the pain scale, where the patient is asked to observe the pain he/she feels and quantify it from 0 to 10, 0 being no pain and 10 being maximum pain; and the manual pressure force (MPF) where a maximum grip force is applied for a time of 3 seconds, with a rest of 1 minute between each repetition, making two attempts, measuring both times to obtain the best value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of subcutaneous polyvidone collagen treatment in quality of life in adult rheumatoid arthritis | 2 months | Quality of life will be assessed through the short SF-36 questionnaire. Applied at the time of the interview with each of the participants before and after the intervention in both groups. |
Countries
Mexico
Outcome results
None listed