To hear about similar clinical trials, please enter your email below
Trial Title:
Effect of Subcutaneous Polyvidone Collagen Treatment on Hand Recovery in Adult Rheumatoid Arthritis.
NCT ID:
NCT06656169
Condition:
Arthritis, Rheumatoid
Conditions: Official terms:
Arthritis
Arthritis, Rheumatoid
Povidone
Conditions: Keywords:
Rheumatoid Arthritis
Collagen Polyvidone
Synovial Tissue
Tumor necrosis factor-alpha
American College of Rheumatology Questionnaire
Rheumatoid Factor
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
A double-blind, randomized, masked, placebo-controlled, randomized clinical trial will be
conducted
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Subcutaneous polyvidone collagen
Description:
Use collagen-polyvidone at a dose of 0.2 ml, applied to the affected area of the hand.
Arm group label:
Case group
Other name:
Fibroquel
Intervention type:
Other
Intervention name:
saline solution
Description:
administer saline solution at a dose of 0.2 ml, applied to the affected area of the hand.
Arm group label:
Control group
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.
Criteria for 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.
Gender:
All
Minimum age:
60 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Western Speciality Hospital, Mexican Social Security Institute
Address:
City:
Guadalajara
Zip:
44329
Country:
Mexico
Status:
Recruiting
Contact:
Last name:
Clotilde Fuentes-Orozco, M.D, Ph.D
Phone:
523331154287
Email:
clotilde.fuentes@gmail.com
Facility:
Name:
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
Address:
City:
Guadalajara
Zip:
44329
Country:
Mexico
Status:
Recruiting
Start date:
January 1, 2024
Completion date:
January 5, 2026
Lead sponsor:
Agency:
Instituto Mexicano del Seguro Social
Agency class:
Other
Source:
Instituto Mexicano del Seguro Social
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06656169
