Induction of Cure in Early Arthritis. A single blind randomized clinical trial.

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 111

Inclusion Criteria

Inclusion criteria
- >=18 and < 65 years 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 and at least two swollen and painful joints
- 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

Exclusion Criteria

Exclusion criteria
- Alcohol or substance abuse, current smoking or a long history of smoking
- 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 <60%
- 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 or increased risk
for major cardiovascular events as assessed by the treating rheumatologist.
Risk of arterial thrombosis is based on calculation of the cardiovascular
SCORE, which includes cholesterol ratio, systolic blood pressure, age, gender,
diabetes, history of cardiovascular disease and smoking status. Only patients
in the green category of the NHG CVRM risk table will be included
- Increased risk of malignancy; this includes patients with a history of a
malignancy (except basal cell carcinoma, and squamous cell carcinoma, and
cervical carcinoma in situ and other malignancies that have been treated
curatively >10 years ago, for instance types of thyroid cancer) and patients
with syndrome which increase cancer risk (e.g. BRCA/HNPCC/LYNCH).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters/endpoints<br /><br>- decrease in disease activity at 3 months</p><br>

Secondary Outcome Measures

Name	Time	Method

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