AzTrials
AzTrials

Arthritis, RheumatoidPhase 1/2NCT06656169

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

A Phase 1/2 study testing Subcutaneous polyvidone collagen and saline solution in people with Arthritis, Rheumatoid, run by Instituto Mexicano del Seguro Social at 2 sites in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Arthritis, Rheumatoid
What is being tested?
Subcutaneous polyvidone collagen and saline solution
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
2 sitesMexico
Study dates
1 Jan 2021to 7 Jan 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

2 sites in 1 country.

Mexico2 sites

  • National Western Speciality Hospital, Mexican Social Security Institute

    Guadalajara, Jalisco, 44329

  • 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

Other trials in Mexico

About this study

Official title: Effect of Subcutaneous Polyvidone Collagen Treatment vs Placebo on Clinical Hand Recovery, Biochemical Response and Quality of Life in Adult Rheumatoid Arthritis.

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.

Read the 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.

Being tested
Subcutaneous polyvidone collagen, saline solution
Keywords
Rheumatoid Arthritis, Collagen Polyvidone, Synovial Tissue, Tumor necrosis factor-alpha, American College of Rheumatology Questionnaire, Rheumatoid Factor
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Subcutaneous polyvidone collagenDrug

    Also called Fibroquel

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

  • saline solutionOther

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

Study groups in NCT06656169
Study groupRoleWhat they receive
Case groupExperimentalPatients with unilateral or bilateral arthritic hand, both genders, age of 60 years or older in treatment with subcutaneous polyvidone collagen.
Receives: Drug: Subcutaneous polyvidone collagen
Control groupPlacebo comparatorPatients with unilateral or bilateral arthritic hand, both genders, age of 60 years or older
Receives: Other: saline solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Every 15 days for 2 months

Secondary outcomes (1)

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

    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.

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2024
  2. Study start1 Jan 2021
  3. Primary completion6 Jan 2023
  4. Study completion7 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A double-blind, randomized, masked, placebo-controlled, randomized clinical trial will be conducted
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06656169
Sponsor's protocol ID
Polyvidone collagen effect
Status last verified
Oct 2024
First submitted
3 Oct 2024
Last updated
1 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30870218

  • 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.

    PubMed 31980337

  • 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.

    PubMed 10415784

  • 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.

    PubMed 31511227

  • 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.

    PubMed 30023036

  • 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.

    PubMed 32341463

  • 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.

    PubMed 33113770

  • 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.

    PubMed 30285183

  • 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.

    PubMed 27810462

  • 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.

    PubMed 29290762

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Subcutaneous polyvidone collagen and saline solution in people with Arthritis, Rheumatoid, run by Instituto Mexicano del Seguro Social at 2 sites in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: Every 15 days for 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06656169, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in