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

NCT06656169 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: Polyvidone collagen effect
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Arthritis, Rheumatoid

Keywords

Rheumatoid Arthritis; Collagen Polyvidone; Synovial Tissue; Tumor necrosis factor-alpha; American College of Rheumatology Questionnaire; Rheumatoid Factor

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Every 15 days for 2 months

Secondary Outcomes (1)

• Effect of subcutaneous polyvidone collagen treatment in quality of life in adult rheumatoid arthritis

  2 months

Study Arms (2)

Case group

EXPERIMENTAL

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

Drug: Subcutaneous polyvidone collagen

Control group

PLACEBO COMPARATOR

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

Other: saline solution

Interventions

Subcutaneous polyvidone collagen DRUG

Use collagen-polyvidone at a dose of 0.2 ml, applied to the affected area of the hand.

Also known as: Fibroquel

Case group

saline solution OTHER

administer saline solution at a dose of 0.2 ml, applied to the affected area of the hand.

Control group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (2)

National Western Speciality Hospital, Mexican Social Security Institute

Guadalajara, Jalisco, 44329, Mexico

Location

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

Guadalajara, Jalisco, 44329, Mexico

Location

Related Publications (10)

• Furuzawa-Carballeda J, Alcocer-Varela J, Diaz de Leon L. Collagen-PVP decreases collagen turnover in synovial tissue cultures from rheumatoid arthritis patients. Ann N Y Acad Sci. 1999 Jun 30;878:598-602. doi: 10.1111/j.1749-6632.1999.tb07738.x. No abstract available.

  PMID: 10415784 BACKGROUND

• Day AL, Curtis JR. Opioid use in rheumatoid arthritis: trends, efficacy, safety, and best practices. Curr Opin Rheumatol. 2019 May;31(3):264-270. doi: 10.1097/BOR.0000000000000602.

  PMID: 30870218 BACKGROUND

• Safiri S, Kolahi AA, Hoy D, Smith E, Bettampadi D, Mansournia MA, Almasi-Hashiani A, Ashrafi-Asgarabad A, Moradi-Lakeh M, Qorbani M, Collins G, Woolf AD, March L, Cross M. Global, regional and national burden of rheumatoid arthritis 1990-2017: a systematic analysis of the Global Burden of Disease study 2017. Ann Rheum Dis. 2019 Nov;78(11):1463-1471. doi: 10.1136/annrheumdis-2019-215920. Epub 2019 Sep 11.

  PMID: 31511227 BACKGROUND

• Alaya Z, Braham M, Aissa S, Kalboussi H, Bouajina E. A case of Caplan syndrome in a recently diagnosed patient with silicosis: A case report. Radiol Case Rep. 2018 Apr 11;13(3):663-666. doi: 10.1016/j.radcr.2018.03.004. eCollection 2018 Jun.

  PMID: 30023036 BACKGROUND

• Curran AM, Naik P, Giles JT, Darrah E. PAD enzymes in rheumatoid arthritis: pathogenic effectors and autoimmune targets. Nat Rev Rheumatol. 2020 Jun;16(6):301-315. doi: 10.1038/s41584-020-0409-1. Epub 2020 Apr 27.

  PMID: 32341463 BACKGROUND

• Scherer HU, Haupl T, Burmester GR. The etiology of rheumatoid arthritis. J Autoimmun. 2020 Jun;110:102400. doi: 10.1016/j.jaut.2019.102400. Epub 2020 Jan 22.

  PMID: 31980337 BACKGROUND

• Damerau A, Gaber T. Modeling Rheumatoid Arthritis In Vitro: From Experimental Feasibility to Physiological Proximity. Int J Mol Sci. 2020 Oct 25;21(21):7916. doi: 10.3390/ijms21217916.

  PMID: 33113770 BACKGROUND

• Aletaha D, Smolen JS. Diagnosis and Management of Rheumatoid Arthritis: A Review. JAMA. 2018 Oct 2;320(13):1360-1372. doi: 10.1001/jama.2018.13103.

  PMID: 30285183 BACKGROUND

• Leon L, Abasolo L, Fernandez-Gutierrez B, Jover JA, Hernandez-Garcia C. Direct medical costs and their predictors in the EMAR-II cohort: "Variability in the management of rheumatoid arthritis and spondyloarthritis in Spain". Reumatol Clin (Engl Ed). 2018 Jan-Feb;14(1):4-8. doi: 10.1016/j.reuma.2016.09.006. Epub 2016 Oct 31. English, Spanish.

  PMID: 27810462 BACKGROUND

• Kobak S, Bes C. An autumn tale: geriatric rheumatoid arthritis. Ther Adv Musculoskelet Dis. 2018 Jan;10(1):3-11. doi: 10.1177/1759720X17740075. Epub 2017 Nov 7.

  PMID: 29290762 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Clotilde Fuentes, 1

  IMSS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A double-blind, randomized, masked, placebo-controlled, randomized clinical trial will be conducted

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 24, 2024
• Study Start: January 1, 2021
• Primary Completion: January 6, 2023
• Study Completion: January 7, 2023
• Last Updated: May 1, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ME (2)