early inflammatory joint complaints early unclassified arthritis
Conditions
Interventions
Intervention
After giving informed consent, patients will be randomized to three treatment
arms:
-arm 1: treat symptomatically with NSAID or COXIB and a single dose of
intramuscular or local intra-
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria - >=18 and 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: 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 3x upper limit of normal - Renal insufficiency with estimated creatinine clearance 10 years ago, for instance types of thyroid cancer) and patients with syndrome which increase cancer risk (e.g. BRCA/HNPCC/LYNCH).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters/endpoints - decrease in disease activity at 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters/endpoints: -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) - General satisfaction with medication use (convenience) on a 100 mm VAS (no to maximum) - General dissatisfaction with medication use on a 100 mm VAS (no to maximum) - The extent to which benefits of medication use are more important than downsides on a 100 mm VAS (no to maximum) - Feelings of depression as measured with the Hospital Axiety and Depression Scale (HADS) -Time to clinical remission from baseline and per drug (MTX or baricitinib) from start of treatment -Time to clinical improvement (by patient diary and clinical assessments at weeks 2,4 and 8) -Progression to classifiable RA (2010 criteria) over time from baseline -Time to flare (from absence of any arthritis to at least one joint with active arthritis) -(Progression of) radiologic damage as measured with the Sharp-vanderHeijde Score (screening, 6, and 12 months) -Disease activity as assessed by the treating rheumatologist on a 100 mm VAS at 3 months and 12 months and over time | — |
Countries
Netherlands
Outcome results
None listed