Osteoarthritis, KneeARPAINNCT03533569
Early Biomarkers for ARthritic PAIN to Guide Improved Treatments for Arthritis
An observational study of Osteoarthritis, Knee and Rheumatoid Arthritis, run by St George's, University of London at 1 site in United Kingdom.
Trial summary
Osteoarthritis (OA) is a condition affecting the whole joint and is a major cause of pain and disability worldwide. Although OA is very common, the initial steps which lead to the development of pain and tissue damage are not fully understood. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee, Rheumatoid Arthritis, Spondyloarthritis
- What is being tested?
- Intra-articular corticosteroid injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Apr 2018to 2 Apr 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population includes participants with an established diagnosis of knee osteoarthritis, rheumatoid arthritis, spondyloarthritis or psoriatic arthritis. A control group without arthritis or knee pain serves as the comparator group
Who may be able to join
- Fulfilling the American College of Rheumatology (ACR) criteria for the diagnosis of knee osteoarthritis
- Symptomatic knee pain
- On usual care for knee osteoarthritis including paracetamol and/or NSAIDs
- Fulfilling the American College of Rheumatology (ACR) criteria for the diagnosis of inflammatory arthritis i.e. rheumatoid arthritis (Anti-CCP antibodies \& Rheumatoid Factor checked ), psoriatic arthritis or spondyloarthropathy
- Symptomatic knee pain
- On usual care for arthritis including disease-modifying anti-rheumatic drugs (DMARDs), paracetamol and/or NSAIDs
Who cannot join
- Other rheumatological diagnosis e.g. systemic lupus erythematosus, fibromyalgia, Polymyalgia Rheumatica, Gout, Giant Cell Arteritis, Sjogren's syndrome
- History of uncontrolled depression
- Recent surgery
- Uncontrolled ischaemic heart disease
- Uncontrolled diabetes mellitus
- Alcohol consumption > 14 units/week as per UK National guidelines
- Participants unable to give full informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
St George's Healthcare NHS Trust
London, SW17 0RE
Abiola Ms Harrison, BSc, 4402082666474, oharriso@sgul.ac.uk
Nidhi Dr Sofat, MD, PhD
About this study
Official title: Early Biomarkers for ARthritic PAIN to Guide Improved Treatments for Arthritis (ARPAIN) Study
Osteoarthritis (OA) is a condition affecting the whole joint and is a major cause of pain and disability worldwide. Although OA is very common, the initial steps which lead to the development of pain and tissue damage are not fully understood. In this study participants will be investigated for markers in the blood, joint and urine in people who have a diagnosis of osteoarthritis or inflammatory arthritis and are receiving a steroid injection for their condition. Markers will be evaluated in participants with osteoarthritis compared with other types of arthritis, including rheumatoid arthritis and spondyloarthritis.
Read the detailed description
Osteoarthritis (OA) is the most common form of arthritis worldwide. OA causes major disability and pain and places a huge financial burden on healthcare worldwide. In recent work, the gene expression profile of bone marrow lesions (BML) in osteoarthritis has been evaluated. BML in OA have a novel gene expression profile which includes genes involved in inflammation, neurogenesis and matrix turnover. The plan is to investigate the functional significance of the genes found at the protein biomarker level in studies of joint tissue, blood and urine from participants with knee OA and compare these changes with participants who have other forms of arthritis, including rheumatoid arthritis and spondyloarthritis.
A study amendment was added in April 2020 due to Covid-19. We are studying up to 150 additional participants with or without inflammatory conditions who are being treated with immunomodulatory drugs compared with participants who are not on immunomodulators. We will be evaluating the course of Covid-19 infection in people without autoimmune inflammatory conditions, compared with people who have autoimmune inflammatory diseases who are on immunomodulators.
- Being tested
- Intra-articular corticosteroid injection
- Keywords
- pain, inflammation
- Medical subject headings
- Osteoarthritis, Knee, Arthritis, Rheumatoid, Spondylarthritis, Arthritis, Psoriatic, Pain, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular corticosteroid injectionProcedure or surgery
Participants with arthritis will undergo usual care with knee synovial fluid aspiration followed by intra-articular corticosteroid injection
| Study group | Role | What they receive |
|---|---|---|
| Osteoarthritis | Participants with an established diagnosis of knee osteoarthritis Receives: Procedure: Intra-articular corticosteroid injection | |
| Rheumatoid arthritis | Participants with an established diagnosis of rheumatoid arthritis Receives: Procedure: Intra-articular corticosteroid injection | |
| Spondyloarthritis or psoriatic arthritis | Participants with an established diagnosis of spondyloarthritis or psoriatic arthritis Receives: Procedure: Intra-articular corticosteroid injection | |
| Case controls | Participants with no arthritis or knee pain as controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Numerical Rating Scale (NRS) for pain in target knee after 3 months
Pain outcome measure. The Numerical Rating Scale for pain has a range of 0 - 10, with the lowest score being 0 and the highest rating at 10.The pain rating will be reported by the participants for their symptomatic knee
Measured: Baseline (Visit 1) and 3 months after treatment (Visit 2)
Secondary outcomes (1)
Change in Biomarkers 3 months following treatment
Protein measurements in serum, urine and synovial fluid for type II collagen degradation products in the samples. The levels of type II collagen degradation products may range from 0 to greater than 500 ng/mmol, depending on the stage and severity of the condition
Measured: Baseline (Visit 1) and 3 months after treatment (Visit 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start2 Apr 2018
- Primary completion2 Apr 2021 (estimated)
- Study completion2 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, Rosetrees Trust
- Responsible party
- Sponsor
- Investigators
- Nidhi Dr Sofat, MD, PhD, Principal investigator, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533569
- Sponsor's protocol ID
- 17.0192
- Other IDs
- 17/LO/1894
- Acronym
- ARPAIN
- Status last verified
- Oct 2020
- First submitted
- 17 Apr 2018
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All data will be published and open access after completion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Biomarkers for ARthritic PAIN to Guide Improved Treatments for Arthritis (ARPAIN) Study
- ClinicalTrials.gov ID
- NCT03533569
- Acronym / sponsor ID
- ARPAIN / 17.0192
- Keywords
- pain, inflammation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Collaborators
- Wellcome Trust, Rosetrees Trust
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 2 Apr 2021 (estimated)
- Study completion
- 2 Apr 2022 (estimated)
- First posted
- 23 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osteoarthritis (OA) is a condition affecting the whole joint and is a major cause of pain and disability worldwide. Although OA is very common, the initial steps which lead to the development of pain and tissue damage are not fully understood. In this study participants will be investigated for markers in the blood, joint and urine in people who have a diagnosis of osteoarthritis or inflammatory arthritis and are receiving a steroid injection for their condition. Markers will be evaluated in participants with osteoarthritis compared with other types of arthritis, including rheumatoid arthritis and spondyloarthritis.
Detailed description
Osteoarthritis (OA) is the most common form of arthritis worldwide. OA causes major disability and pain and places a huge financial burden on healthcare worldwide. In recent work, the gene expression profile of bone marrow lesions (BML) in osteoarthritis has been evaluated. BML in OA have a novel gene expression profile which includes genes involved in inflammation, neurogenesis and matrix turnover. The plan is to investigate the functional significance of the genes found at the protein biomarker level in studies of joint tissue, blood and urine from participants with knee OA and compare these changes with participants who have other forms of arthritis, including rheumatoid arthritis and spondyloarthritis.
A study amendment was added in April 2020 due to Covid-19. We are studying up to 150 additional participants with or without inflammatory conditions who are being treated with immunomodulatory drugs compared with participants who are not on immunomodulators. We will be evaluating the course of Covid-19 infection in people without autoimmune inflammatory conditions, compared with people who have autoimmune inflammatory diseases who are on immunomodulators.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Osteoarthritis | – | Procedure: Intra-articular corticosteroid injectionParticipants with an established diagnosis of knee osteoarthritis |
| Rheumatoid arthritis | – | Procedure: Intra-articular corticosteroid injectionParticipants with an established diagnosis of rheumatoid arthritis |
| Spondyloarthritis or psoriatic arthritis | – | Procedure: Intra-articular corticosteroid injectionParticipants with an established diagnosis of spondyloarthritis or psoriatic arthritis |
| Case controls | – | –Participants with no arthritis or knee pain as controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes participants with an established diagnosis of knee osteoarthritis, rheumatoid arthritis, spondyloarthritis or psoriatic arthritis. A control group without arthritis or knee pain serves as the comparator group
Key inclusion criteria (6 listed)
- Fulfilling the American College of Rheumatology (ACR) criteria for the diagnosis of knee osteoarthritis
- Symptomatic knee pain
- On usual care for knee osteoarthritis including paracetamol and/or NSAIDs
- Fulfilling the American College of Rheumatology (ACR) criteria for the diagnosis of inflammatory arthritis i.e. rheumatoid arthritis (Anti-CCP antibodies \& Rheumatoid Factor checked ), psoriatic arthritis or spondyloarthropathy
- Symptomatic knee pain
Key exclusion criteria (7 listed)
- Other rheumatological diagnosis e.g. systemic lupus erythematosus, fibromyalgia, Polymyalgia Rheumatica, Gout, Giant Cell Arteritis, Sjogren's syndrome
- History of uncontrolled depression
- Recent surgery
- Uncontrolled ischaemic heart disease
- Uncontrolled diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-articular corticosteroid injectionParticipants with arthritis will undergo usual care with knee synovial fluid aspiration followed by intra-articular corticosteroid injection | Procedure or surgery | Osteoarthritis, Rheumatoid arthritis, Spondyloarthritis or psoriatic arthritis |
Primary outcome
Change from Baseline Numerical Rating Scale (NRS) for pain in target knee after 3 months
Time frame: Baseline (Visit 1) and 3 months after treatment (Visit 2)
Pain outcome measure. The Numerical Rating Scale for pain has a range of 0 - 10, with the lowest score being 0 and the highest rating at 10.The pain rating will be reported by the participants for their symptomatic knee
1 secondary outcome
Change in Biomarkers 3 months following treatment
Time frame: Baseline (Visit 1) and 3 months after treatment (Visit 2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Individual participant dataSharing planned: Undecided. All data will be published and open access after completion of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nidhi Dr Sofat, MD, PhD principal investigator
St George's, University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee and Rheumatoid Arthritis, run by St George's, University of London at 1 site in United Kingdom.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nidhi Dr Sofat, MD, PhD (4402087250042, nsofat@sgul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Numerical Rating Scale (NRS) for pain in target knee after 3 months (time frame: Baseline (Visit 1) and 3 months after treatment (Visit 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2020.