Osteo Arthritis of the KneePhase 2MTX in knee OANCT07161336
Role of Methotrexate in Ultrasound Proven Synovitis in Primary Knee OA
A Phase 2 study testing Methotrexate (MTX) in people with Osteo Arthritis of the Knee and Synovitis of Knee, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
Background: Osteoarthritis (OA) is a leading cause of disability worldwide, with limited treatment options and many patients suffering from chronic pain. Modern imaging has revealed that OA involves complex changes in cartilage, subchondral bone, and synovium. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Osteo Arthritis of the Knee, Synovitis of Knee, Methotrexate
- What is being tested?
- Methotrexate (MTX)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteBangladesh
- Study dates
- 30 Jul 2025to 30 Aug 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged between 40 to 70 years
- Patients fulfilling American College of Rheumatology (ACR) clinical and radiological criteria for knee OA. (knee pain + at least 3 of 5 that not including "no palpable warmth")
- Knee pain on most days for at least 6 months, with a pain VAS of at least 40mm
- Radiological grading of OA with Kallgren-Lawrence grade of 2 to 3
- Patients with the presence of knee synovitis in Musculoskeletal ultrasound
Who cannot join
- Any known inflammatory arthritis
- BMI >= 40 kg/m2
- Abnormal renal (e.g. abnormal renal function Creatinine clearance <35 ml) hepatic (including active hepatitis B, hepatitis C, abnormal liver function), hematological (e.g. white cell count < 4 × 109/L, platelets <100 ×109/L, or hemoglobin < 9 g/dL), function
- Use of intra-articular, intramuscular or oral corticosteroids in previous 4 weeks
- History knee joint surgery, Charcot joint
- Severe valgus knee deformity (angle of genu valgum > 30°)
Show all 9Show fewer
- Use of any disease modifying agents (e.g. hydroxychloroquine or sulfasalazine) in previous 3 months
- Allergic to MTX
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site, 1 recruiting
- Recruiting
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Dhaka, Dhaka Division
Akash Ahmed Alif, 01726459070, akash.alif@gmail.com
akash.alif@gmail.com
About this study
Official title: Role of Methotrexate in Ultrasound Proven Synovitis in Patients With Knee Osteoarthritis : A Randomized Controlled Trial
Background:
Osteoarthritis (OA) is a leading cause of disability worldwide, with limited treatment options and many patients suffering from chronic pain. Modern imaging has revealed that OA involves complex changes in cartilage, subchondral bone, and synovium. Pain in OA is often linked to synovitis, which is common in the condition. Methotrexate (MTX), a proven treatment for synovitis in inflammatory arthritis like rheumatoid arthritis and has a well-known safety profile. The proposal suggests that using MTX may have potential to treat symptomatic knee OA with USG (musculoskeletal ultrasound) proven synovitis by reducing synovitis and as a result, alleviate pain.
Read more
Objectives:
To assess the role of methotrexate in primary knee osteoarthritis associated with ultrasound proven synovitis.
Methods:
This randomized Controlled trial will be conducted in the department of Rheumatology, Bangladesh Medical University (BMU) from July 2025 to June 2026. A total of 70 patients will be enrolled with primary knee OA diagnosed on the basis of ACR Criteria for Knee OA with informed written consent. MSK USG examinations of knee joint and scoring (OMERACT SCORE) will be performed to detect synovitis by a rheumatologist expert in MSK US. Then randomization will be done into group A and group B following a randomization table, each consisting of 35 patients. Consecutive sampling techniques will be followed. One group will receive MTX (start with 15 mg per week for the first 2 weeks then increase to 20 mg and continue for the remaining period if tolerated) and Both groups of patients will be allowed to take NSAIDs on a requirement basis with documentation and follow non-pharmacological treatment of OA. At the end of 3rd and 6th month pain and functional status will be assessed by WOMAC, VAS and quality of life will be assessed by using Bangla version of SF-12. At the end of 6th month improvement of synovitis will be seen by MSK USG of involved knees with OMERACT scoring. Primary endpoint for efficacy will be assessed at the end of 24th week by WOMAC. Secondary endpoints will be determined by VAS and SF-12. Adverse effects will be assessed by history, physical examinations and investigations. The data will be analyzed by using the latest version SPSS software (Version 29). Results will be recorded using means and standard deviations. Results will be compared among two groups with a 95% confidence interval and a p- value of < 0.05 will be considered statistically significant. The degrees of statistical significance between groups will be analyzed by unpaired t test (for quantitative normally distributed data) and Mann Whitney U test if there is skewed distribution. Qualitative data in between groups will be analyzed by the chi square test. Probabilities of associations will be assessed by calculating Pearson's rank correlation coefficient. P-value <0.05 will be regarded as statistically significant. The nature, purpose and implication of the study as well as the entire spectrum of benefits and risks of study will be explained to the patients. Privacy and confidentiality of the subject will be maintained. Each patient will enjoy the right to participate and or withdraw from the study at any point of the study period. Ethical clearance will be obtained from the institutional Review Board (IRB) of BMU.
- Conditions
- Osteo Arthritis of the Knee, Synovitis of Knee, Methotrexate
- Being tested
- Methotrexate (MTX), Placebo
- Keywords
- knee OA, synovitis, Methotrexate
- Medical subject headings
- Synovitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methotrexate (MTX)Drug
Also called MTX, Low dose Methotrexate
One group will receive MTX, starting with 15 mg per week for the first 2 weeks then increase to 20 mg and continue for the remaining period if tolerated. another group will receive placebo
PlaceboDrug
The investigational drug and the placebo will be formulated to be identical in appearance, packaging, labeling. Blinded study medications will be prepared, packaged, and labeled by the sponsor according to Good Manufacturing Practice (GMP) standards. All packaging will use neutral labeling with unique subject numbers only.
| Study group | Role | What they receive |
|---|---|---|
| Methotrexate (MTX) | Active comparator | As it will be a double blinded study , the investigator and the patient is unable to know if the drug is MTX or placebo Receives: Drug: Methotrexate (MTX) |
| Placebo | Placebo comparator | As it will be a double blinded study , the investigator and the patient is unable to know if the drug is MTX or placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the role of Methotrexate to change the functional status with Western Ontario and McMaster Universities Osteoarthritis Index in patients with ultrasound proven synovitis associated with primary knee Osteoarthritis.
This Western Ontario and McMaster Universities Osteoarthritis Index have 24 questions divided in 3 domains ( PAIN, Stiffness, Difficulty in performing daily activities) each of the 24 questions having a visual analog scale of 0-10.Patients will score themselves between 0-10 for each question . So the minimum score will be 0 and the maximum score will be 240 .The higher the number more severe the condition.
Measured: 6 months
Secondary outcomes (2)
changes in synovitis by Outcome Measures in Rheumatology (OMERACT) scoring in patients with primary knee OA.
Outcome Measures in Rheumatology (OMERACT) scoring of USG findings of knee joint have 7 domains , each of the domains will be scored based on the ultrasound findings like the following.
USG findings
- Synovitis 0 1 2 3
- Cartilage damage 0 1 2 3
- Meniscal damage 0 1 2
- Osteophytes : 0 1 2 3
- Synovial hypertrophy : Present=1or Absent=0
- Effusion : Present=1 or Absent=0
- Synovial PD signal : Present=1 or Absent=0
The higher the number more severe the condition
Measured: 6 months
Change in Quality of life through 12-item Short-Form Health Survey (SF-12) in patients with primary knee OA
The 12-Item Short Form Survey (SF-12v2) is a 12- item questionnaire used to assess generic health outcomes from a patient's perspective. SF-12 is used to measure physical and mental components of health in patients with any chronic illness on a broad range of functional domains. The SF-12 consists of a subset of 12 items drawn from SF-36. covering the same eight domains of health outcomes measuring physical functioning (PF), role physical (RP, physical health problems), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE, emotional problems) and mental health (MH). Higher scores represent better health status. Score more than 50 is better and below 50 is considered lower than average.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start30 Jul 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis of the 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Double blind randomized controlled trial study will be carried out in the outpatient department of rheumatology in BMU to determine the efficacy of Methotrexate in the treatment of primary knee OA associated with synovitis. Ethical approval will be taken from the Ethical Review Committee of BMU, Dhaka. At first, patients who attend the outpatient rheumatology department with knee pain will be requested to give verbal consent. Then, primary knee OA will be diagnosed by ACR clinical and radiological criteria, and subsequently, history, physical examination, and investigation will be done for evaluation of exclusion criteria. Then MSKUS examinations of knee joint and scoring (OMERACT SCORE) will be performed to detect synovitis by one rheumatologist experienced in MSK ultrasound using a MINDRAY machine with an 6-18 MHz linear array transducer operating at 3 MHz Power Doppler (PD) signal settings will be Pulse repetition frequency 750Hz, Doppler frequency 11.1 MHz, gain of 50% and low wa
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akash Ahmed Alif, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Shamim Ahmed Professor, FCPS, Study chair, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161336
- Sponsor's protocol ID
- 5535
- Acronym
- MTX in knee OA
- Status last verified
- Aug 2025
- First submitted
- 30 Aug 2025
- Last updated
- 12 Sep 2025
- 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 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Methotrexate in Ultrasound Proven Synovitis in Patients With Knee Osteoarthritis : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07161336
- Acronym / sponsor ID
- MTX in knee OA / 5535
- Conditions
- Osteo Arthritis of the Knee, Synovitis of Knee, Methotrexate
- Keywords
- knee OA, synovitis, Methotrexate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 8 Sep 2025 (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.
Background:
Osteoarthritis (OA) is a leading cause of disability worldwide, with limited treatment options and many patients suffering from chronic pain. Modern imaging has revealed that OA involves complex changes in cartilage, subchondral bone, and synovium. Pain in OA is often linked to synovitis, which is common in the condition. Methotrexate (MTX), a proven treatment for synovitis in inflammatory arthritis like rheumatoid arthritis and has a well-known safety profile. The proposal suggests that using MTX may have potential to treat symptomatic knee OA with USG (musculoskeletal ultrasound) proven synovitis by reducing synovitis and as a result, alleviate pain.
Objectives:
To assess the role of methotrexate in primary knee osteoarthritis associated with ultrasound proven synovitis.
Methods:
This randomized Controlled trial will be conducted in the department of Rheumatology, Bangladesh Medical University (BMU) from July 2025 to June 2026. A total of 70 patients will be enrolled with primary knee OA diagnosed on the basis of ACR Criteria for Knee OA with informed written consent. MSK USG examinations of knee joint and scoring (OMERACT SCORE) will be performed to detect synovitis by a rheumatologist expert in MSK US. Then randomization will be done into group A and group B following a randomization table, each consisting of 35 patients. Consecutive sampling techniques will be followed. One group will receive MTX (start with 15 mg per week for the first 2 weeks then increase to 20 mg and continue for the remaining period if tolerated) and Both groups of patients will be allowed to take NSAIDs on a requirement basis with documentation and follow non-pharmacological treatment of OA. At the end of 3rd and 6th month pain and functional status will be assessed by WOMAC, VAS and quality of life will be assessed by using Bangla version of SF-12. At the end of 6th month improvement of synovitis will be seen by MSK USG of involved knees with OMERACT scoring. Primary endpoint for efficacy will be assessed at the end of 24th week by WOMAC. Secondary endpoints will be determined by VAS and SF-12. Adverse effects will be assessed by history, physical examinations and investigations. The data will be analyzed by using the latest version SPSS software (Version 29). Results will be recorded using means and standard deviations. Results will be compared among two groups with a 95% confidence interval and a p- value of < 0.05 will be considered statistically significant. The degrees of statistical significance between groups will be analyzed by unpaired t test (for quantitative normally distributed data) and Mann Whitney U test if there is skewed distribution. Qualitative data in between groups will be analyzed by the chi square test. Probabilities of associations will be assessed by calculating Pearson's rank correlation coefficient. P-value <0.05 will be regarded as statistically significant. The nature, purpose and implication of the study as well as the entire spectrum of benefits and risks of study will be explained to the patients. Privacy and confidentiality of the subject will be maintained. Each patient will enjoy the right to participate and or withdraw from the study at any point of the study period. Ethical clearance will be obtained from the institutional Review Board (IRB) of BMU.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A Double blind randomized controlled trial study will be carried out in the outpatient department of rheumatology in BMU to determine the efficacy of Methotrexate in the treatment of primary knee OA associated with synovitis. Ethical approval will be taken from the Ethical Review Committee of BMU, Dhaka. At first, patients who attend the outpatient rheumatology department with knee pain will be requested to give verbal consent. Then, primary knee OA will be diagnosed by ACR clinical and radiological criteria, and subsequently, history, physical examination, and investigation will be done for evaluation of exclusion criteria. Then MSKUS examinations of knee joint and scoring (OMERACT SCORE) will be performed to detect synovitis by one rheumatologist experienced in MSK ultrasound using a MINDRAY machine with an 6-18 MHz linear array transducer operating at 3 MHz Power Doppler (PD) signal settings will be Pulse repetition frequency 750Hz, Doppler frequency 11.1 MHz, gain of 50% and low wa
| Arm | Type | Receives |
|---|---|---|
| Methotrexate (MTX) | Active comparator | Drug: Methotrexate (MTX)As it will be a double blinded study , the investigator and the patient is unable to know if the drug is MTX or placebo |
| Placebo | Placebo comparator | Drug: PlaceboAs it will be a double blinded study , the investigator and the patient is unable to know if the drug is MTX or placebo |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women aged between 40 to 70 years
- Patients fulfilling American College of Rheumatology (ACR) clinical and radiological criteria for knee OA. (knee pain + at least 3 of 5 that not including "no palpable warmth")
- Knee pain on most days for at least 6 months, with a pain VAS of at least 40mm
- Radiological grading of OA with Kallgren-Lawrence grade of 2 to 3
- Patients with the presence of knee synovitis in Musculoskeletal ultrasound
Key exclusion criteria (9 listed)
- Any known inflammatory arthritis
- BMI >= 40 kg/m2
- Abnormal renal (e.g. abnormal renal function Creatinine clearance <35 ml) hepatic (including active hepatitis B, hepatitis C, abnormal liver function), hematological (e.g. white cell count < 4 × 109/L, platelets <100 ×109/L, or hemoglobin < 9 g/dL), function
- Use of intra-articular, intramuscular or oral corticosteroids in previous 4 weeks
- History knee joint surgery, Charcot joint
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 |
|---|---|---|
| Methotrexate (MTX)Also: MTX, Low dose MethotrexateOne group will receive MTX, starting with 15 mg per week for the first 2 weeks then increase to 20 mg and continue for the remaining period if tolerated. another group will receive placebo | Drug | Methotrexate (MTX) |
| PlaceboThe investigational drug and the placebo will be formulated to be identical in appearance, packaging, labeling. Blinded study medications will be prepared, packaged, and labeled by the sponsor according to Good Manufacturing Practice (GMP) standards. All packaging will use neutral labeling with unique subject numbers only. | Drug | Placebo |
Primary outcome
To assess the role of Methotrexate to change the functional status with Western Ontario and McMaster Universities Osteoarthritis Index in patients with ultrasound proven synovitis associated with primary knee Osteoarthritis.
Time frame: 6 months
This Western Ontario and McMaster Universities Osteoarthritis Index have 24 questions divided in 3 domains ( PAIN, Stiffness, Difficulty in performing daily activities) each of the 24 questions having a visual analog scale of 0-10.Patients will score themselves between 0-10 for each question . So the minimum score will be 0 and the maximum score will be 240 .The higher the number more severe the condition.
2 secondary outcomes
changes in synovitis by Outcome Measures in Rheumatology (OMERACT) scoring in patients with primary knee OA.
Time frame: 6 months
Change in Quality of life through 12-item Short-Form Health Survey (SF-12) in patients with primary knee OA
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
Related trials for Osteo Arthritis of the Knee
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
Not yet recruitingPhase 3
A Study to Evaluate Efficacy and Safety of a Single Intra-Articular Injection of HL-01 in the Treatment of Pain in Symptomatic Knee Osteoarthritis
Osteo Arthritis of the Knee
Recruiting
Total Versus Robotic Assisted Unicompartmental Knee Replacement
Osteo Arthritis Knee, Arthritis Knee
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.
Shamim Ahmed Professor, FCPS study chair
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methotrexate (MTX) in people with Osteo Arthritis of the Knee and Synovitis of Knee, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 12 Sep 2025. 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 Bangladesh. 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 phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Akash Ahmed Alif, MBBS (+8801726459070 ext. +8801825484701, akash.alif@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the role of Methotrexate to change the functional status with Western Ontario and McMaster Universities Osteoarthritis Index in patients with ultrasound proven synovitis associated with primary knee Osteoarthritis. (time frame: 6 months). 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 Sep 2025.