Induction of Cure in Early Arthritis

Phase 1

• Conditions: early unclassified arthritis; MedDRA version: 21.0Level: PTClassification code 10062164Term: Seronegative arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2019-004359-35-NL
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-10
• Last Update Posted: 15 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 309

Inclusion Criteria

-=18 year of age and able to give written informed consent (in Dutch or English) and fill out questionnaires in Dutch (or English version, if available)
-Clinical early unclassified arthritis of at least one joint, not fulfilling ACR/EULAR 2010 criteria for rheumatoid arthritis
-Symptom duration of arthritis <1 year
-Other diagnoses causing the arthritis rejected (including infection, (pseudo-)gout, psoriatic arthritis, non-rheumatoid auto-immune disease, paraneoplastic arthritis)
-DAS>1.6
-No wish to become pregnant, breastfeed or father a child during the study
-No contraindications to treatment with NSAIDs, MTX (or sulfasalazine or leflunomide as alternative) and baricitinib as required in the study
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 245
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 64

Exclusion Criteria

-Alcohol or substance abuse
-Immuno-compromised state either based on co-morbidity or co-medication
-Leucopenia <3*10^9/l, and/or neutropenia <1*10^9/l
-Hemoglobin <5 mmol/l
-Increased liver enzymes > 3x upper limit of normal
-Renal insufficiency with estimated creatinine clearance <40%
-Interstitial lung disease as seen on X-thorax
-Maintenance treatment with corticosteroids exceeding prednisone 10 mg daily or equivalent
-Active or ongoing chronic infection, (recurrent) serious infection(s) in past 4 months, latent TB who refuse anti-tuberculous treatment, hepatitis B with positive DNA viral load or hepatitis C with positive RNA viral load, patients with anti-HB2 and anti-HBc antibodies who refuse monitoring of hepatitis B DNA expression
-Increased tendency to develop arterial or venous thrombosis. Assessed by the treating rheumatologist based on family history and medical history of the patient.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified