I CEA. Induction of Cure in Early ArthritisA single blind randomized clinical trial
- Conditions
- undifferentiated arthritis
- Registration Number
- NL-OMON29280
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
expected in leading rheumatology journals
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 300
18 years or older, able to give written informed consent (in Dutch or English) and fill out questionnaires in Dutch (or English version, if available), undifferentiated arthritis with symptom duration <1 year, not fulfilling classification criteria for rheumatoid arthritis, other diagnoses causing the arthritis rejected, Disease Activity Score >1.6
Contraindications to use of study medication or reasonable alternatives
Wish to become pregnant, breastfeed or father a child during the study
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Percentage in remission at 3 months. 2. Percentage in sustained (at least 6 previous months) drug free remission.
- Secondary Outcome Measures
Name Time Method