A Post-trial Follow-up of MERINO Participants to Evaluate Long-term Effects of Methotrexate Treatment in Adults With Erosive Hand OA.

Hand Osteoarthritis Clinical Trial

— MERINO:2  

Official title:

A One-year Post-trial Observation of MERINO Participants (MERINO:2): An Open-label Observational Study to Investigate Long-term Effects of Methotrexate in Male and Female Adults With Erosive Hand Osteoarthritis.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06281184
• Other study ID #: DIA2024.1
• Secondary ID: 715758
• Status: Not yet recruiting
• Start date: March 15, 2024
• Est. completion date: February 1, 2027

Study information

• Verified date: February 2024
• Source: Diakonhjemmet Hospital
• Contact: Alexander Mathiessen, MD PhD
• Phone: +4797501889
• Email: alexander_mathiessen[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 108
• Est. completion date: February 1, 2027
• Est. primary completion date: February 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Participants completing the MERINO trial, i.e. having erosive hand OA and being randomized to MTX or placebo for 12 months.

Related Conditions & MeSH terms

• Erosive Osteoarthritis
• Hand Osteoarthritis
• Osteoarthritis

Intervention

Drug:
• Methotrexate
Methotrexate 10-20 mg x 1 per week, combined with folic acid 1mg daily.

Other:
• No treatment
No specific treatment after MERINO-trial

Locations

Country	Name	City	State
Norway	Diakonhjemmet Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Diakonhjemmet Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Secondary	Effect of MTX on pain, function and life quality	• Finger joint pain previous 48 hours (VAS) at 12 months • Thumb base joint pain previous 48 hours (VAS) at 12 months • Pain most painful finger joint previous 48 hours (VAS) at 12 months • AUSCAN pain and function subscales at 12 months • OMERACT-OARSI responder criteria at 12 months • Patient-reported disease activity previous 48 hours (VAS) at 12 months • EQ-5D at 12 months	12 months
Secondary	Effect of MTX on radiographic progression of hand OA.	• KL grades • OARSI atlas (osteophytes, joint space narrowing, erosions)	12 months