Hand OsteoarthritisPhase 4MERINONCT04579848
Methotrexate in Erosive Inflammatory Hand Osteoarthritis
A Phase 4 study testing Methotrexate Tablets and Folic Acid 1 MG in people with Hand Osteoarthritis and Erosive Osteoarthritis, run by Diakonhjemmet Hospital at 1 site in Norway.
Trial summary
A placebo-controlled randomized controlled trial exploring the effect of methotrexate on pain, function and structural outcomes in erosive inflammatory hand osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Osteoarthritis, Erosive Osteoarthritis
- What is being tested?
- Methotrexate Tablets and Folic Acid 1 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 163 participants
- Where
- 1 siteNorway
- Study dates
- 12 Aug 2021to Dec 2026
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Finger joint pain 40-80 on 0-100 visual analog scale (VAS) with insufficient pain relief from, inability to tolerate or contra-indications to oral paracetamol and/or NSAIDs, and hand symptoms (pain, aching, or stiffness) on most days the previous 6 weeks before randomization.
- Hand OA according to the American College of Rheumatology (ACR) criteria, at least 1 distal (DIP) or proximal interphalangeal (PIP) joint of the 2nd-5th finger with radiographic pre-erosive (J-phase) or erosive disease (E-phase) according to the Verbruggen-Veys anatomical phase system, and at least two DIP/PIP joints with power Doppler signal of at least grade 1 or grey-scale synovitis of at least grade 2 on ultrasound.
Who cannot join
- A full list of the exclusion criteria for this study comprised the following:
- Contraindications to methotrexate:
- Abnormal renal function, defined as serum creatinine >142 µmol/L in women and >168 µmol/L in men, or a glomeruli filtration rate (GFR) <40 mL/min/1.73 m2.
- Abnormal liver function, defined as transaminases above the upper normal limit, active or previous hepatitis B or C infection, or known cirrhosis
- Lung fibrosis (maximum 6 months old x-ray), active infection, or reduced hematopoiesis (i.e. anemia, leukopenia and/or thrombocytopenia).
- Planned pregnancy within 18 months after screening (men/women), and pregnancy, breastfeeding, or insufficient anti-conception therapy for female fertile participants. Contraception should be maintained during treatment and until the end of systemic exposure, i.e. 3 months after methotrexate discontinuation. Sufficient anti-conception therapy consists of intra-uterine device (coil) or hormonal anti-conception (birth control pills, implant, intra-uterine system, dermal patch, vaginal ring, or injections).
Show all 19Show fewer
- Alcohol or other drug abuse in the last year.
- Intolerance to lactose.
- Chronic inflammatory rheumatic diseases (such as rheumatoid arthritis and psoriatic arthritis or gout), active inflammatory bowel disease, or positive rheumatoid factor or anti-CCP antibodies.
- Other severe co-morbidities such as hemochromatosis, fibromyalgia, psoriasis, blood dyscrasias, and coagulation disorders, history of malignancy (except successfully treated squamous or basal cell skin carcinoma), uncontrolled diabetes mellitus, severe hypertension, unstable ischemic heart disease, severe heart failure, severe pulmonary disease, severe and/or opportunistic infections and/or chronic infections, active tuberculosis, positive human immunodeficiency virus (HIV) status, recent stroke, bone marrow hypoplasia, or demyelinating diseases of the central nervous system.
- Other likely causes of hand symptoms: thoracic outlet syndrome, carpal tunnel disease, diabetic cheiropathy, injury in finger joints previous 6 months, or palmar tenosynovitis/trigger finger.
- Oral or intra-muscular steroids in the previous month
- Intra-articular treatments or aspirations of any kind of any joint in the hands 3 months before inclusion
- Analgesics or NSAIDs, unless stable dosage for ≥1 month.
- Symptomatic slow-acting drugs for OA (SYSADOA), unless stable dose for ≥3 months and require stable dose throughout the study.
- Disease-modifying osteoarthritis drugs (DMOADs) previous three months.
- Scheduled hand surgery during study participation.
- Planning to start other treatments for hand OA in the study participation period.
- Not able to adhere to the study visit schedule and protocol requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Methotrexate in ERosive INflammatory Osteoarthritis (MERINO) Trial: A Randomized Placebo-controlled Trial to Investigate Clinical Efficacy and Safety of Methotrexate in Erosive Inflammatory Hand Osteoarthritis.
A placebo-controlled randomized controlled trial exploring the effect of methotrexate on pain, function and structural outcomes in erosive inflammatory hand osteoarthritis.
Read the detailed description
The trial will include Norwegian adult males and females with symptomatic erosive inflammatory hand osteoarthritis.
Participants will be randomized 1:1 to either:
- Methotrexate oral x 1/week; weekly starting dose 15 mg for two weeks, followed by 20 mg the remaining weeks (intervention group). Dosage can be reduced to as low as 10 mg if higher doses are not tolerated.
- Placebo (control group).
Both arms will receive folic acid 1mg daily.
The treatment duration for both groups is 52 weeks.
- Conditions
- Hand Osteoarthritis, Erosive Osteoarthritis
- Being tested
- Methotrexate Tablets, Placebo, Folic Acid 1 MG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methotrexate TabletsDrug
Methotrexate 2.5mg oral tablet.
PlaceboDrug
Placebo capsule
Folic Acid 1 MGDrug
Folic acid
| Study group | Role | What they receive |
|---|---|---|
| Methotrexate | Active comparator | Methotrexate oral x 1/week; weekly starting dose 15 mg for two weeks, followed by 20 mg the remaining weeks.
Additional Folic acid 1mg prescribed daily. Receives: Drug: Methotrexate Tablets; Drug: Folic Acid 1 MG |
| Placebo | Placebo comparator | 3 capsules per week for two weeks, followed by 4 capsules the remaining weeks.
Additional Folic acid 1mg prescribed daily. Receives: Drug: Placebo; Drug: Folic Acid 1 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Finger pain on a visual analogue scale
Difference in self-reported finger joint pain previous 48 hours on a 0-100 mm scale at 6 months of treatment; higher value indicate worse outcome.
Measured: 6 months
Secondary outcomes (25)
Finger pain on a visual analogue scale
Self-reported finger pain previous 48 hours on a 0-100 mm scale; higher value indicate worse outcome.
Measured: Month 1, 3, 9 and 12.
Thumb pain on a visual analogue scale
Self-reported thumb pain previous 48 hours on a 0-100 mm scale; higher value indicate worse outcome.
Measured: Month 1, 3, 6, 9 and 12.
Pain most painful finger joint on a visual analogue scale
Pain most painful finger joint last 48 hours on a 0-100 mm scale; higher value indicate worse outcome.
Measured: Month 1, 3, 6, 9 and 12.
Patient-reported disease activity on a visual analogue scale
Patient-reported disease activity last 48 hours on a 0-100 mm scale; higher value indicate worse outcome.
Measured: Month 1, 3, 6, 9 and 12.
Pain all joints on a visual analogue scale
Pain all joints last 48 hours on a 0-100 mm scale; higher value indicate worse outcome.
Measured: Month 1, 3, 6, 9 and 12.
Hand diagram pain
Finger pain and thumb base pain (yes/no) on hand diagram
Measured: Month 6.
Body diagram pain
Pain in other joints (yes/no) on body diagram
Measured: Month 6.
AUSCAN
Australian/Canadian hand index (AUSCAN), sum score 0-60, higher value indicate worse outcome.
Measured: Month 1, 3, 6, 9 and 12.
OMERACT-OARSI responder criteria
Fulfillment of Outcome Measures in Rheumatology Osteoarthritis Research Society International (OMERACT-OARSI) responder criteria.
Measured: Month 1, 3, 6, 9 and 12.
EQ-5D
Quality-adjusted life years (QALYs) based on the health-related utility scores measured by the generic instrument EuroQol 5 dimensions (EQ-5D), sum score 5-35, higher value indicate worse outcome, in addition to a 0-100 visual analogue scale where higher value indicate better outcome.
Measured: Month 1, 3, 6, 9 and 12.
MHOQ
Michigan Hand Outcomes Questionnaire (MHOQ) pain and physical function subscales; function subscale range 10-50, higher value indicate worse outcome; task subscale range 17-85, higher value indicate worse outcome; work subscale range 5-25, higher value indicate worse outcome; pain subscale range 10-48, higher value indicate better outcome.
Measured: Month 6.
Grip strength
Grip strength (in kg; using a hand dynamometer)
Measured: Month 1, 3, 6, 9 and 12.
HOOS-12
Hip disability and Osteoarthritis Outcome Score (HOOS)-12, range 12-60, higher value indicate worse outcome.
Measured: Month 6.
KOOS-12
Knee injury and Osteoarthritis Outcome Score (KOOS)-12, range 12-60, higher value indicate worse outcome.
Measured: Month 6.
Concomitant medication
Concomitant medication
Measured: Month 1, 3, 6, 9 and 12.
Tender and swollen joints
Number of tender and swollen joints (range 0-30), higher values indicate more affected joints.
Measured: Month 1, 3, 6, 9 and 12.
Physician-reported disease activity on a visual analogue scale
Patient-reported disease activity on a 0-100 mm scale; higher value indicate worse outcome.
Measured: Month 1, 3, 6, 9 and 12.
Hand radiographs: Kellgren Lawrence
Conventional radiographs: change in radiographic severity according to Kellgren-Lawrence scale, range 0-4 in each joint higher value indicate worse outcome.
Measured: Month 6 and 12
Hand radiographs: Verbruggen-Veys anatomical phase scoring system
Conventional radiographs: radiographic severity in finger joints according to Verbruggen-Veys anatomical phase scoring system, range 1-5; higher value indicate worse outcome.
Measured: Month 6 and 12
Hand radiographs: OARSI atlas
Conventional radiographs: rdiographic severity according to the Osteoarthritis Research Society International (OARSI) atlas for the presence/severity of osteophytes, joint space narrowing and erosions.
Measured: Month 6 and 12
Hand MRI
MRI of dominant hand: number of joints with synovitis and BMLs
Measured: Month 6
Hand ultrasound
Ultrasound: number of finger joints with synovial thickening and power Doppler signals.
Measured: Month 1, 3, 6, 9 and 12.
Knee ultrasound
Ultrasound: degree of synovitis in knee joints
Measured: Month 6
Hip ultrasound
Ultrasound: degree of synovitis in hip joints
Measured: Month 6
Adverse events
Number of adverse events, serious adverse events, and withdrawals because of adverse events.
Measured: Through study completion, maximum 12 months, in addition to 3 months after end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start12 Aug 2021
- Primary completion2 Sep 2026
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand OsteoarthritisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An investigator-initiated, randomized, double-blinded, placebo-controlled, parallel-group, single-center, phase IV, superiority study, exploring the effect of methotrexate on pain, function and structural outcomes in erosive inflammatory hand osteoarthritis.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 163 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diakonhjemmet Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Principal investigator, Ida Kristin Haugen, Diakonhjemmet Hospital
- Investigators
- Tore K Kvien, MD, PhD, Study chair, Professor Em.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579848
- Sponsor's protocol ID
- DIA2020-01
- Acronym
- MERINO
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2020
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The trialists and other study personnel that conceive of the study, and then plan, manage, monitor, analyze and publish it, will have access to IPD. Participants' identification code numbers are de-identified by replacing the original code number with a new random code number. Only the PI and project coordinator have access to this code. The protocol, SAP, ICF, and CSR will be shared with regulatory agents as required.
Publications
Mathiessen A, Gaundal L, Sexton J, Sjolie D, Steen Pettersen P, Slatkowsky-Christensen B, Haugen IK. Protocol for the MERINO study: A randomized placebo-controlled trial assessing the efficacy, safety, and cost-effectiveness of methotrexate in people with erosive hand osteoarthritis. Osteoarthr Cartil Open. 2024 Dec 15;7(1):100558. doi: 10.1016/j.ocarto.2024.100558. eCollection 2025 Mar.
PubMed 39807424
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Methotrexate in ERosive INflammatory Osteoarthritis (MERINO) Trial: A Randomized Placebo-controlled Trial to Investigate Clinical Efficacy and Safety of Methotrexate in Erosive Inflammatory Hand Osteoarthritis.
- ClinicalTrials.gov ID
- NCT04579848
- Acronym / sponsor ID
- MERINO / DIA2020-01
- Conditions
- Hand Osteoarthritis, Erosive Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 163 participants (estimated)
- Lead sponsor
- Diakonhjemmet HospitalUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 2 Sep 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Oct 2020 (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.
A placebo-controlled randomized controlled trial exploring the effect of methotrexate on pain, function and structural outcomes in erosive inflammatory hand osteoarthritis.
Detailed description
The trial will include Norwegian adult males and females with symptomatic erosive inflammatory hand osteoarthritis.
Participants will be randomized 1:1 to either:
- Methotrexate oral x 1/week; weekly starting dose 15 mg for two weeks, followed by 20 mg the remaining weeks (intervention group). Dosage can be reduced to as low as 10 mg if higher doses are not tolerated.
- Placebo (control group).
Both arms will receive folic acid 1mg daily.
The treatment duration for both groups is 52 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- An investigator-initiated, randomized, double-blinded, placebo-controlled, parallel-group, single-center, phase IV, superiority study, exploring the effect of methotrexate on pain, function and structural outcomes in erosive inflammatory hand osteoarthritis.
| Arm | Type | Receives |
|---|---|---|
| Methotrexate | Active comparator | Drug: Methotrexate Tablets, Drug: Folic Acid 1 MGMethotrexate oral x 1/week; weekly starting dose 15 mg for two weeks, followed by 20 mg the remaining weeks. Additional Folic acid 1mg prescribed daily. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Folic Acid 1 MG3 capsules per week for two weeks, followed by 4 capsules the remaining weeks. Additional Folic acid 1mg prescribed daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Finger joint pain 40-80 on 0-100 visual analog scale (VAS) with insufficient pain relief from, inability to tolerate or contra-indications to oral paracetamol and/or NSAIDs, and hand symptoms (pain, aching, or stiffness) on most days the previous 6 weeks before randomization.
- Hand OA according to the American College of Rheumatology (ACR) criteria, at least 1 distal (DIP) or proximal interphalangeal (PIP) joint of the 2nd-5th finger with radiographic pre-erosive (J-phase) or erosive disease (E-phase) according to the Verbruggen-Veys anatomical phase system, and at least two DIP/PIP joints with power Doppler signal of at least grade 1 or grey-scale synovitis of at least grade 2 on ultrasound.
Key exclusion criteria (19 listed)
- Contraindications to methotrexate:
- Chronic inflammatory rheumatic diseases (such as rheumatoid arthritis and psoriatic arthritis or gout), active inflammatory bowel disease, or positive rheumatoid factor or anti-CCP antibodies.
- Other severe co-morbidities such as hemochromatosis, fibromyalgia, psoriasis, blood dyscrasias, and coagulation disorders, history of malignancy (except successfully treated squamous or basal cell skin carcinoma), uncontrolled diabetes mellitus, severe hypertension, unstable ischemic heart disease, severe heart failure, severe pulmonary disease, severe and/or opportunistic infections and/or chronic infections, active tuberculosis, positive human immunodeficiency virus (HIV) status, recent stroke, bone marrow hypoplasia, or demyelinating diseases of the central nervous system.
- Other likely causes of hand symptoms: thoracic outlet syndrome, carpal tunnel disease, diabetic cheiropathy, injury in finger joints previous 6 months, or palmar tenosynovitis/trigger finger.
- Oral or intra-muscular steroids in the previous month
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 TabletsMethotrexate 2.5mg oral tablet. | Drug | Methotrexate |
| PlaceboPlacebo capsule | Drug | Placebo |
| Folic Acid 1 MGFolic acid | Drug | Methotrexate, Placebo |
Primary outcome
Finger pain on a visual analogue scale
Time frame: 6 months
Difference in self-reported finger joint pain previous 48 hours on a 0-100 mm scale at 6 months of treatment; higher value indicate worse outcome.
25 secondary outcomes
Finger pain on a visual analogue scale
Time frame: Month 1, 3, 9 and 12.
Thumb pain on a visual analogue scale
Time frame: Month 1, 3, 6, 9 and 12.
Pain most painful finger joint on a visual analogue scale
Time frame: Month 1, 3, 6, 9 and 12.
Patient-reported disease activity on a visual analogue scale
Time frame: Month 1, 3, 6, 9 and 12.
Pain all joints on a visual analogue scale
Time frame: Month 1, 3, 6, 9 and 12.
Hand diagram pain
Time frame: Month 6.
Body diagram pain
Time frame: Month 6.
AUSCAN
Time frame: Month 1, 3, 6, 9 and 12.
OMERACT-OARSI responder criteria
Time frame: Month 1, 3, 6, 9 and 12.
EQ-5D
Time frame: Month 1, 3, 6, 9 and 12.
MHOQ
Time frame: Month 6.
Grip strength
Time frame: Month 1, 3, 6, 9 and 12.
HOOS-12
Time frame: Month 6.
KOOS-12
Time frame: Month 6.
Concomitant medication
Time frame: Month 1, 3, 6, 9 and 12.
Tender and swollen joints
Time frame: Month 1, 3, 6, 9 and 12.
Physician-reported disease activity on a visual analogue scale
Time frame: Month 1, 3, 6, 9 and 12.
Hand radiographs: Kellgren Lawrence
Time frame: Month 6 and 12
Hand radiographs: Verbruggen-Veys anatomical phase scoring system
Time frame: Month 6 and 12
Hand radiographs: OARSI atlas
Time frame: Month 6 and 12
Hand MRI
Time frame: Month 6
Hand ultrasound
Time frame: Month 1, 3, 6, 9 and 12.
Knee ultrasound
Time frame: Month 6
Hip ultrasound
Time frame: Month 6
Adverse events
Time frame: Through study completion, maximum 12 months, in addition to 3 months after end of treatment.
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 3 Nov 2026.
- Derived from this study: PubMed 39807424Mathiessen A, Gaundal L, Sexton J, Sjolie D, Steen Pettersen P, Slatkowsky-Christensen B, Haugen IK. Protocol for the MERINO study: A randomized placebo-controlled trial assessing the efficacy, safety, and cost-effectiveness of methotrexate in people with erosive hand osteoarthritis. Osteoarthr Cartil Open. 2024 Dec 15;7(1):100558. doi: 10.1016/j.ocarto.2024.100558. eCollection 2025 Mar.
- Individual participant dataSharing planned: No. The trialists and other study personnel that conceive of the study, and then plan, manage, monitor, analyze and publish it, will have access to IPD. Participants' identification code numbers are de-identified by replacing the original code number with a new random code number. Only the PI and project coordinator have access to this code. The protocol, SAP, ICF, and CSR will be shared with regulatory agents as required.
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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.
Tore K Kvien, MD, PhD study chair
Professor Em.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methotrexate Tablets and Folic Acid 1 MG in people with Hand Osteoarthritis and Erosive Osteoarthritis, run by Diakonhjemmet Hospital at 1 site in Norway.
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 2 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. 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 Norway. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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?
Finger pain on a visual analogue scale (time frame: 6 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 NCT04579848, which also lists 1 linked publication.
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 3 Nov 2026.