The MERINO trial

Phase 4

Not yet recruiting

• Conditions: Erosive hand osteoarthritis

• Registration Number: 2023-510523-30-00
• Lead Sponsor: Diakonhjemmet Sykehus AS

Brief Summary

To explore whether methotrexate can reduce finger joint pain in patients with symptomatic erosive inflammatory hand OA.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-02-09
• Last Update Posted: 2024-02-09

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 153

Inclusion Criteria

Finger joint pain 40-80 on 0-100 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 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.

Exclusion Criteria

• Contraindications for methotrexate, such as uncontrolled serious comorbidities, active or recurrent infections, malignancy, pregnancy and drug or substance abuse. • Other autoimmune or inflammatory rheumatic disease, or psoriasis. • 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, unless stable dosage for ≥1 month. • Symptomatic slow-acting drugs for OA (SYSADOA*), unless stable dose for ≥3 months. • Disease modifying osteoarthritis drugs (DMOADs**). The complete list of exclusion criteria is provided in the protocol.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in self-reported finger joint pain previous 48 hours on a visual analogue scale (VAS; 0-100 mm) at 6 months (M06) of treatment.		Difference in self-reported finger joint pain previous 48 hours on a visual analogue scale (VAS; 0-100 mm) at 6 months (M06) of treatment.

Secondary Outcome Measures

Name	Time	Method
Fulfillment of Outcome Measures in Rheumatology Osteoarthritis Research Society International (OMERACT-OARSI) responder criteria (all visits).		Fulfillment of Outcome Measures in Rheumatology Osteoarthritis Research Society International (OMERACT-OARSI) responder criteria (all visits).
Self-reported finger pain previous 48 hours on a VAS (0-100 mm) (all visits).		Self-reported finger pain previous 48 hours on a VAS (0-100 mm) (all visits).
Self-reported thumb pain previous 48 hours on a VAS (0-100 mm) (all visits).		Self-reported thumb pain previous 48 hours on a VAS (0-100 mm) (all visits).
Pain most painful finger joint last 48 hours (VAS) (all visits).		Pain most painful finger joint last 48 hours (VAS) (all visits).
Finger pain and thumb base pain (yes/no) on hand diagram (M00, M06).		Finger pain and thumb base pain (yes/no) on hand diagram (M00, M06).
Patient-reported disease activity last 48 hours (VAS) (all visits).		Patient-reported disease activity last 48 hours (VAS) (all visits).
Australian/Canadian hand index (AUSCAN) (all visits).		Australian/Canadian hand index (AUSCAN) (all visits).
Quality-adjusted life years (QALYs) based on the health-related utility scores measured by the generic instrument EQ-5D (all visits).		Quality-adjusted life years (QALYs) based on the health-related utility scores measured by the generic instrument EQ-5D (all visits).
Michigan Hand Outcomes Questionnaire (MHOQ) pain and physical function subscales (M00, M06).		Michigan Hand Outcomes Questionnaire (MHOQ) pain and physical function subscales (M00, M06).
Duration of morning stiffness in finger joints (M00, M06)		Duration of morning stiffness in finger joints (M00, M06)
Duration of morning stiffness in thumb base joints (M00, M06)		Duration of morning stiffness in thumb base joints (M00, M06)
Hospital Anxiety and Depression Scales (HADS) (M00, M06).		Hospital Anxiety and Depression Scales (HADS) (M00, M06).
Pain Catastrophizing Scale (PCS) (M00, M06).		Pain Catastrophizing Scale (PCS) (M00, M06).
Pain Sensitivity Questionnaire (PSQ) (M00, M06).		Pain Sensitivity Questionnaire (PSQ) (M00, M06).
Knee injury and Osteoarthritis Outcome Score (KOOS)-12 (M00, M06).		Knee injury and Osteoarthritis Outcome Score (KOOS)-12 (M00, M06).
Hip disability and Osteoarthritis Outcome Score (HOOS)-12 (M00, M06).		Hip disability and Osteoarthritis Outcome Score (HOOS)-12 (M00, M06).
Concomitant medication (all visits).		Concomitant medication (all visits).
Number of tender and swollen joints (0-30) (all visits).		Number of tender and swollen joints (0-30) (all visits).
Grip strength (in kg; using a hand dynamometer) (M00, M06, M12).		Grip strength (in kg; using a hand dynamometer) (M00, M06, M12).
Pain sensitization: Pressure Pain Thresholds (PPT) by digital algometer; temporal summation by punctate probes; Conditioned Pain Modulation (CPM) by blood pressure ischemic test (M00, M06).		Pain sensitization: Pressure Pain Thresholds (PPT) by digital algometer; temporal summation by punctate probes; Conditioned Pain Modulation (CPM) by blood pressure ischemic test (M00, M06).
Ultrasound (screening, all visits): number of finger joints with synovial thickening and power Doppler signals.		Ultrasound (screening, all visits): number of finger joints with synovial thickening and power Doppler signals.
Conventional radiographs (screening, M06, M12): change in radiographic severity according to: o Kellgren-Lawrence scale o Verbruggen-Veys anatomical phase scoring system o Osteoarthritis Research Society International (OARSI) atlas for the presence/severity of osteophytes, joint space narrowing and erosions		Conventional radiographs (screening, M06, M12): change in radiographic severity according to: o Kellgren-Lawrence scale o Verbruggen-Veys anatomical phase scoring system o Osteoarthritis Research Society International (OARSI) atlas for the presence/severity of osteophytes, joint space narrowing and erosions
MRI (M00, M06): structural progression and synovitis on static and dynamic contrast-enhanced MRI sequences.		MRI (M00, M06): structural progression and synovitis on static and dynamic contrast-enhanced MRI sequences.
Serum or plasma markers of extracellular matrix turnover, including collagens and aggrecan, and markers of inflammation (M00, M06, M12).		Serum or plasma markers of extracellular matrix turnover, including collagens and aggrecan, and markers of inflammation (M00, M06, M12).
Number of adverse events, serious adverse events, and withdrawals because of adverse events (all visits).		Number of adverse events, serious adverse events, and withdrawals because of adverse events (all visits).
Change in synovial cellular composition and gene expression with single-cell RNA sequencing analyses; subgroup analyses, n=16 patients (M00, M06).		Change in synovial cellular composition and gene expression with single-cell RNA sequencing analyses; subgroup analyses, n=16 patients (M00, M06).
Self-reported knee pain previous 48 hours on a VAS (0-100) (M00, M06).		Self-reported knee pain previous 48 hours on a VAS (0-100) (M00, M06).

Trial Locations

Locations (1)

Diakonhjemmet Sykehus AS; 🇳🇴 Oslo, Norway

Diakonhjemmet Sykehus AS

🇳🇴Oslo, Norway

Ida Kristin Bos-Haugen

Site contact

+4795859884

ida.k.haugen@gmail.com