Hand OsteoarthritisMERINO:2NCT06281184
A 30-month Follow-up of MERINO Participants to Evaluate Long-term Effects of Methotrexate in Erosive Hand OA.
An observational study of Hand Osteoarthritis and Erosive Osteoarthritis, run by Diakonhjemmet Hospital at 1 site in Norway.
Trial summary
In response to the high prevalence of synovitis in hand osteoarthritis (OA) and its association with pain, there\'s a compelling rationale for investigating the efficacy of MTX in managing inflammatory erosive hand OA. 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 and Treatment as usual
- How many people
- 108 participants
- Where
- 1 siteNorway
- Study dates
- 29 Jul 2024to 1 Dec 2027
- Phase
- Observational
- 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
Study population: Eligible participants are those enrolled in the MERINO-trial (EudraCT number 2019-004641-33, Clincaltrials.gov number NCT04579848, REK ID 2020/187524, CTIS number 2023-510523-30-00).
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
- 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).
- Alcohol or other drug abuse in the last year.
Show all 18Show fewer
- 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. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Long-term Effects of Methotrexate in Adults With Erosive Hand Osteoarthritis: A 30-month Follow-up of Former MERINO Participants (MERINO:2).
In response to the high prevalence of synovitis in hand osteoarthritis (OA) and its association with pain, there\&#39;s a compelling rationale for investigating the efficacy of MTX in managing inflammatory erosive hand OA. Recent guidelines highlight the need for large, well-designed trials to assess the effectiveness of MTX. A recent trial (METHODS study) showed promising pain reduction with MTX, but due to pandemic-related protocol changes, the duration of the study was limited to six months. The ongoing MERINO trial randomizes participants to MTX or placebo for one year. After completing the MERINO trial, several participants asked for MTX open label. In the subsequent MERINO:2 study, participants completing the trial will be invited to a structured follow-up after one year, including electronic questionnaires and hand radiographs, providing valuable long-term data on the effects of MTX in hand OA. Together, these trials aim to fill gaps in understanding the long-term impact of MTX in hand OA, particularly on structural progression.
Read the detailed description
The primary aim is to demonstrate the superiority of Methotrexate (MTX) over no treatment in slowing radiographic progression over 24 months in individuals with erosive hand osteoarthritis (OA).
OA is a leading cause of disability and affecting millions worldwide, with a significant impact on knee, hip, and hand joints. Despite its high prevalence and symptomatic burden, effective disease-modifying treatments remain elusive, with current options limited to pain management and joint replacement.
MTX, recognized for its disease-modifying effects in systemic inflammatory joint diseases, offers promising potential in OA treatment, with previous trials indicating its anti-inflammatory properties and potential for joint damage reduction. In the ongoing MERINO trial, 153 participants are randomly assigned to either MTX or a placebo. Following completion of the trial, several participants have expressed interest in MTX treatment, which is sometimes used off-label for erosive hand OA patients experiencing unmanageable pain and inflammation. As a result, some MERINO trial participants will receive MTX treatment.
In the MERINO:2 study, we will conduct a structured follow-up one year post-MERINO trial completion, incorporating hand radiographs and pain questionnaires. This endeavor will furnish invaluable insights into the long-term effects of MTX treatment in erosive hand OA, a gap in current knowledge, particularly regarding structural progression. This will provide valuable data on long-term effects of MTX treatment in erosive hand OA, which is not currently described in the literature, especially on structural progression.
- Conditions
- Hand Osteoarthritis, Erosive Osteoarthritis
- Being tested
- Methotrexate, Treatment as usual
- Keywords
- Erosive hand osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Methotrexate 5-25 mg x 1 per week, combined with folic acid 1mg daily.
Treatment as usualOther
No specific treatment after MERINO-trial
| Study group | Role | What they receive |
|---|---|---|
| MTX -- MTX | MERINO trial: randomized to methotrexate (MTX) MERINO:2 study: continues with MTX Receives: Drug: Methotrexate | |
| MTX -- Treatment as usual | MERINO trial: randomized to methotrexate (MTX) MERINO:2 study: continues without MTX Receives: Other: Treatment as usual | |
| Placebo -- MTX | MERINO trial: randomized to placebo MERINO:2 study: continues with MTX Receives: Drug: Methotrexate | |
| Placebo -- Treatment as usual | MERINO trial: randomized to placebo MERINO:2 study: continues without MTX Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of MTX on radiographic progression of erosive hand OA.
Effect of MTX on radiographic progression of erosive hand OA according to Verbruggen-Veys anatomical atlas score at 12 months
Measured: 18 months
Secondary outcomes (2)
Effect of MTX on pain, function and life quality
- Finger joint pain previous 48 hours (VAS) at 18 months • Thumb base joint pain previous 48 hours (VAS) at 18 months • Pain most painful finger joint previous 48 hours (VAS) at 18 months • AUSCAN pain and function subscales at 18 months • OMERACT-OARSI responder criteria at 18 months • Patient-reported disease activity previous 48 hours (VAS) at 18 months • EQ-5D at 18 months
Measured: 18 months
Effect of MTX on radiographic progression of hand OA.
- KL grades • OARSI atlas (osteophytes, joint space narrowing, erosions)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start29 Jul 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diakonhjemmet Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281184
- Sponsor's protocol ID
- DIA2024.1
- Other IDs
- 715758
- Acronym
- MERINO:2
- Status last verified
- Apr 2025
- First submitted
- 20 Feb 2024
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects of Methotrexate in Adults With Erosive Hand Osteoarthritis: A 30-month Follow-up of Former MERINO Participants (MERINO:2).
- ClinicalTrials.gov ID
- NCT06281184
- Acronym / sponsor ID
- MERINO:2 / DIA2024.1
- Conditions
- Hand Osteoarthritis, Erosive Osteoarthritis
- Keywords
- Erosive hand osteoarthritis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Diakonhjemmet HospitalUniversity, hospital or other
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 28 Feb 2024 (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.
In response to the high prevalence of synovitis in hand osteoarthritis (OA) and its association with pain, there\&#39;s a compelling rationale for investigating the efficacy of MTX in managing inflammatory erosive hand OA. Recent guidelines highlight the need for large, well-designed trials to assess the effectiveness of MTX. A recent trial (METHODS study) showed promising pain reduction with MTX, but due to pandemic-related protocol changes, the duration of the study was limited to six months. The ongoing MERINO trial randomizes participants to MTX or placebo for one year. After completing the MERINO trial, several participants asked for MTX open label. In the subsequent MERINO:2 study, participants completing the trial will be invited to a structured follow-up after one year, including electronic questionnaires and hand radiographs, providing valuable long-term data on the effects of MTX in hand OA. Together, these trials aim to fill gaps in understanding the long-term impact of MTX in hand OA, particularly on structural progression.
Detailed description
The primary aim is to demonstrate the superiority of Methotrexate (MTX) over no treatment in slowing radiographic progression over 24 months in individuals with erosive hand osteoarthritis (OA).
OA is a leading cause of disability and affecting millions worldwide, with a significant impact on knee, hip, and hand joints. Despite its high prevalence and symptomatic burden, effective disease-modifying treatments remain elusive, with current options limited to pain management and joint replacement.
MTX, recognized for its disease-modifying effects in systemic inflammatory joint diseases, offers promising potential in OA treatment, with previous trials indicating its anti-inflammatory properties and potential for joint damage reduction. In the ongoing MERINO trial, 153 participants are randomly assigned to either MTX or a placebo. Following completion of the trial, several participants have expressed interest in MTX treatment, which is sometimes used off-label for erosive hand OA patients experiencing unmanageable pain and inflammation. As a result, some MERINO trial participants will receive MTX treatment.
In the MERINO:2 study, we will conduct a structured follow-up one year post-MERINO trial completion, incorporating hand radiographs and pain questionnaires. This endeavor will furnish invaluable insights into the long-term effects of MTX treatment in erosive hand OA, a gap in current knowledge, particularly regarding structural progression. This will provide valuable data on long-term effects of MTX treatment in erosive hand OA, which is not currently described in the literature, especially on structural progression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MTX -- MTX | – | Drug: MethotrexateMERINO trial: randomized to methotrexate (MTX) MERINO:2 study: continues with MTX |
| MTX -- Treatment as usual | – | Other: Treatment as usualMERINO trial: randomized to methotrexate (MTX) MERINO:2 study: continues without MTX |
| Placebo -- MTX | – | Drug: MethotrexateMERINO trial: randomized to placebo MERINO:2 study: continues with MTX |
| Placebo -- Treatment as usual | – | Other: Treatment as usualMERINO trial: randomized to placebo MERINO:2 study: continues without MTX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible participants are those enrolled in the MERINO-trial (EudraCT number 2019-004641-33, Clincaltrials.gov number NCT04579848, REK ID 2020/187524, CTIS number 2023-510523-30-00).
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 (18 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 |
|---|---|---|
| MethotrexateMethotrexate 5-25 mg x 1 per week, combined with folic acid 1mg daily. | Drug | MTX -- MTX, Placebo -- MTX |
| Treatment as usualNo specific treatment after MERINO-trial | Other | MTX -- Treatment as usual, Placebo -- Treatment as usual |
Primary outcome
Effect of MTX on radiographic progression of erosive hand OA.
Time frame: 18 months
Effect of MTX on radiographic progression of erosive hand OA according to Verbruggen-Veys anatomical atlas score at 12 months
2 secondary outcomes
Effect of MTX on pain, function and life quality
Time frame: 18 months
Effect of MTX on radiographic progression of hand OA.
Time frame: 18 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 24 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Hand Osteoarthritis
Active, not recruiting
Balneotherapy in Hand Osteoarthritis
Hand Osteoarthritis
Active, not recruitingPhase 4
Methotrexate in Erosive Inflammatory Hand Osteoarthritis
Hand Osteoarthritis, Erosive Osteoarthritis
Recruiting
Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
Thumb Osteoarthritis, Thumb Carpometacarpal Joint Osteoarthritis
Active, not recruitingPhase 2
Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of STT Osteoarthritis
Osteoarthritis Hand
RecruitingPhase 2/3
Methotrexate Treatment in Hand Osteoarthritis Refractory to Usual Treatments
Erosive Hand Osteoarthritis
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.
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?
An observational study of 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 18 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: enrolling by invitation, as of the sponsor's last update on 24 Apr 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 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. 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?
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?
Effect of MTX on radiographic progression of erosive hand OA. (time frame: 18 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 24 Apr 2025.