Norwegian adult males and females with symptomatic erosive inflammatory hand osteoarthritis. MedDRA version: 21.1 Level: LLT Classification code 10016686 Term: Finger osteoarthritis System Organ Class: 100000004859 MedDRA version: 21.1 Level: LLT Classification code 10019115 Term: Hand osteoarthritis System Organ Class: 100000004859 MedDRA version: 21.0 Level: LLT Classification code 10064565 Term: Erosive osteoarthritis System Organ Class: 100000004859
Conditions
Interventions
Trade Name: Methotrexate Pfizer 2,5 mg oral tablet
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Sponsors
Diakonhjemmet Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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 osteoarthritis 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 130 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore whether methotrexate can reduce finger joint pain in patients with symptomatic erosive inflammatory hand osteoarthritis.;Secondary Objective: •To explore whether methotrexate can improve other patient-reported outcomes (such as physical function, stiffness, health-related quality of life), markers of pain sensitization and grip strength. •To analyze whether methotrexate reduces joint inflammation reflected by both imaging and soluble biomarkers, and potential associations between symptom reduction and reduced inflammation. •To determine whether methotrexate treatment reduces structural progression. •Exploratory: person and disease characteristics as predictors for treatment response and identify sensitive imaging, soluble and genetic biomarkers for monitoring disease activity. •To evaluate the cost effectiveness of methotrexate compared to standard care.;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Patient-reported outcome measures: • 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 thumb pain previous 48 hours on a VAS (0-100 mm) (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). • Patient-reported disease activity last 48 hours (VAS) (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). • 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 thumb base joints (M00, M06) • Hospital Anxiety and Depression Scales (HADS) (M00, M06). • Pain Catastrophizing Scale (PCS) (M00, M06). • Pain Sensitivity Questionnaire (PSQ) (M00, M06). • Knee injury and Osteoarthritis Outcome Score (KOOS)-12 (M00, M06). • Concomitant medication (all visits). Clinical outcome measures: • Number of tender and swollen joints (0-30) (all visits). • Grip strength (in kg; using a hand dynamometer) (all visits). • 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). Imaging: • 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 spac | — |
Countries
Norway
Contacts
Public ContactPrincipal investigator
Diakonhjemmet Hospital
Outcome results
None listed