undifferentiated arthritis
Conditions
Interventions
All arms: one intraarticular or intramuscular injection with corticosteroids (40 mg methylprednisolone or equivalent). Arm 1: start with NSAID (naproxen 2 dd 500 mg or equivalent). If no remission aft
Sponsors
Eli Lilly and Company
Eligibility
Inclusion criteria
Inclusion criteria: 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 1.6
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percentage in remission at 3 months. 2. Percentage in sustained (at least 6 previous months) drug free remission. | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Activity Score (DAS) based on a 44 swollen joint count including a 53 joint Ritchie Articular Index. Functional ability as measured by the Health Assessment Questionnaire (HAQ) Physical and emotional wellbeing as measured by the ShortForm-36 (SF-36) Functional ability in preferred activities as measured by the MACTAR Quality of life as measured by the EuroQol 5-dimensional questionnaire (EQ-5D) Toxicity as defined by number and severity of adverse events based on routine laboratory tests as required for study medications, open end questioning during study visits, and interim reports of adverse events Local joint pain as measured on a 100 mm Visual Analogue Scale (VAS), measuring from 0 (no pain) to 100 (maximum imaginable pain) General fatigue as measured on a 100 mm VAS (no to maximum) Morning stiffness as measured on a 100 mm VAS (no to maximum) General functional disability as measured on a 100 mm VAS (no to maximum) Feelings of depression as measured with the Beck’s Depression Inventory Treatment satisfaction as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM) | — |
Contacts
Public ContactCornelia Allaart
Leiden University Medical Center
Outcome results
None listed