Reduction in PainHand OA & MTXNCT01927484
Hand OA AND Methotrexate Use
A study testing 25 mg/week oral methotrexate tablets in people with Reduction in Pain and Reduction of Inflammation, run by University of Alexandria at 1 site in Egypt.
Trial summary
Osteoarthritis (OA) is a common disabling condition, for which no effective therapy currently exists. Synovitis has been demonstrated in hand OA imaging. Synovial inflammation due to the release of cytokines is an important cause of pain. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Reduction in Pain, Reduction of Inflammation, Improvement in Function
- What is being tested?
- 25 mg/week oral methotrexate tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Mar 2020to 11 Mar 2020
- Phase
- Interventional
- 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
- primary knee osteoarthritis
- persistent pain
- synovitis
Who cannot join
- rheumatoid arthritis
- gout and pseudogout
- traumatic arthritis
- other secondary arthritis
- renal disease
- liver disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Methotrexate in Hand Osteoarthritis
Osteoarthritis (OA) is a common disabling condition, for which no effective therapy currently exists. Synovitis has been demonstrated in hand OA imaging. Synovial inflammation due to the release of cytokines is an important cause of pain. Methotrexate (MTX) helps to decrease synovitis in many inflammatory joint diseases, particularly rheumatoid arthritis.
The aim of the present study is to assess the efficacy of MTX in decreasing pain and inflammation in symptomatic hand OA.
Methods: One hundred and twenty patients with American College of Rheumatology (ACR) clinical and radiographic criteria of primary knee OA with hand pain, [>4 on the 24-hour average pain severity scale (0-10) using mean of daily ratings from week preceding randomization] for > 14 days/month during 3 consecutive months preceding enrollment will be included in this randomized double-blind placebo-controlled trial. Patients meeting the eligibility criteria were randomized in a 1:1 ratio to receive either 25mg/week oral MTX (n=60) or placebo (n=60) together with their usual therapy provided the dosages were kept constant for 28 weeks. Pain will be assessed using the Visual Analogue pain Scale, (VAS, 0-100 mm). Functional assessment will be performed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Activities of daily living (ADL) scores. Alterations in dosage of analgesic/NSAID drugs used will be recorded. Safety and tolerability will also be assessed. Synovitis will be detected by ultrasound imaging.
- Being tested
- 25 mg/week oral methotrexate tablets, 25mg/week oral placebo tablets
- Keywords
- methotrexate,, osteoarthritis,, pain,, function,, synovitis
- Medical subject headings
- Osteoarthritis, Pain, Synovitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25 mg/week oral methotrexate tabletsDrug
Also called interventional drug
active oral methotrexate drug
25mg/week oral placebo tabletsDrug
placebo comparator oral drug
| Study group | Role | What they receive |
|---|---|---|
| methotrexate | Experimental | 25mg oral methotrexate tablets Receives: Drug: 25 mg/week oral methotrexate tablets |
| placebo | Placebo comparator | 25 mg/week placebo tablets Receives: Drug: 25mg/week oral placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain reduction
The primary outcome will be pain reduction at 28 weeks compared to baseline using a Visual Analogue Pain Scale (VAS) 0-100 mm. Data will be collected at baseline and monthly up to 28 weeks to determine any change in results from those obtained at baseline.
Measured: 28 weeks
Secondary outcomes (1)
physical function improvement Functional assessment
Improvements in physical functioning McMaster Universities Osteoarthritis Index (WOMAC) subscores for pain, stiffness and function , the patient global assessment of the severity of knee OA measured on a 0-100 mm VAS. The physician-reported disease activity VAS was also recorded. Data will be collected at baseline and monthly up to 28 weeks to determine any change in results from those obtained at baseline.
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2013 (estimated)
- Study start7 Mar 2020
- Primary completion11 Mar 2020
- Study completion11 Mar 2020
Why it stopped: due to COVID-19 Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reduction in PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Abou-Raya, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927484
- Sponsor's protocol ID
- alexmed1391963211975
- Acronym
- Hand OA & MTX
- Status last verified
- Aug 2020
- First submitted
- 16 Aug 2013
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methotrexate in Hand Osteoarthritis
- ClinicalTrials.gov ID
- NCT01927484
- Acronym / sponsor ID
- Hand OA & MTX / alexmed1391963211975
- Keywords
- methotrexate,, osteoarthritis,, pain,, function,, synovitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to COVID-19 Pandemic
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of AlexandriaUniversity, hospital or other
- Study start
- 7 Mar 2020 (actual)
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 11 Mar 2020 (actual)
- First posted
- 22 Aug 2013 (estimated)
- 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 common disabling condition, for which no effective therapy currently exists. Synovitis has been demonstrated in hand OA imaging. Synovial inflammation due to the release of cytokines is an important cause of pain. Methotrexate (MTX) helps to decrease synovitis in many inflammatory joint diseases, particularly rheumatoid arthritis.
The aim of the present study is to assess the efficacy of MTX in decreasing pain and inflammation in symptomatic hand OA.
Methods: One hundred and twenty patients with American College of Rheumatology (ACR) clinical and radiographic criteria of primary knee OA with hand pain, [>4 on the 24-hour average pain severity scale (0-10) using mean of daily ratings from week preceding randomization] for > 14 days/month during 3 consecutive months preceding enrollment will be included in this randomized double-blind placebo-controlled trial. Patients meeting the eligibility criteria were randomized in a 1:1 ratio to receive either 25mg/week oral MTX (n=60) or placebo (n=60) together with their usual therapy provided the dosages were kept constant for 28 weeks. Pain will be assessed using the Visual Analogue pain Scale, (VAS, 0-100 mm). Functional assessment will be performed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Activities of daily living (ADL) scores. Alterations in dosage of analgesic/NSAID drugs used will be recorded. Safety and tolerability will also be assessed. Synovitis will be detected by ultrasound imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| methotrexate | Experimental | Drug: 25 mg/week oral methotrexate tablets25mg oral methotrexate tablets |
| placebo | Placebo comparator | Drug: 25mg/week oral placebo tablets25 mg/week placebo tablets |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- primary knee osteoarthritis
- persistent pain
- synovitis
Key exclusion criteria (6 listed)
- rheumatoid arthritis
- gout and pseudogout
- traumatic arthritis
- other secondary arthritis
- renal disease
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 |
|---|---|---|
| 25 mg/week oral methotrexate tabletsAlso: interventional drugactive oral methotrexate drug | Drug | methotrexate |
| 25mg/week oral placebo tabletsplacebo comparator oral drug | Drug | placebo |
Primary outcome
pain reduction
Time frame: 28 weeks
The primary outcome will be pain reduction at 28 weeks compared to baseline using a Visual Analogue Pain Scale (VAS) 0-100 mm. Data will be collected at baseline and monthly up to 28 weeks to determine any change in results from those obtained at baseline.
1 secondary outcome
physical function improvement Functional assessment
Time frame: 28 weeks
Results and safety
The study was stopped early (reason given: due to COVID-19 Pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 25 mg/week oral methotrexate tablets in people with Reduction in Pain and Reduction of Inflammation, run by University of Alexandria at 1 site in Egypt.
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 6 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: stopped early, as of the sponsor's last update on 12 Aug 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 Egypt. 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.
Are results available for this study?
The study was stopped early (reason given: due to COVID-19 Pandemic). Results are not available in the source record.
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?
pain reduction (time frame: 28 weeks). 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 12 Aug 2020.