A randomized placebo-controlled trial to investigate clinical efficacy and safety of methotrexate in erosive inflammatory hand osteoarthritis.

Phase 1

Conditions: orwegian adult males and females with symptomatic erosive inflammatory hand osteoarthritis.
MedDRA version: 21.1Level: LLTClassification code 10016686Term: Finger osteoarthritisSystem Organ Class: 100000004859
MedDRA version: 21.1Level: LLTClassification code 10019115Term: Hand osteoarthritisSystem Organ Class: 100000004859
MedDRA version: 21.0Level: LLTClassification code 10064565Term: Erosive osteoarthritisSystem Organ Class: 100000004859
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2019-004641-33-NO

Lead Sponsor: Diakonhjemmet Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 210

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

•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.