The aim of this study is to establish the efficacy and duration of effect of intra-articular (IA) infliximab vs intravenous infliximab vs current standard care (IA steroid injections) in seronegative oligoarthritis. All patients will have seronegative arthritis affecting less than 5 joints but including at least one knee. 10 patients will receive IA infliximab injections to the affected knee, 10 will receive IA steroid injections to the affected knee and 10 will receive a course of intravenous infliximab. Patients will not be aware of their group as this is a placebo-controlled study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1
intra-articular injection of methylprednisolone (80mg given at baseline only)
intra-articular injection of 100mg infliximab given at baseline only
intravenous infliximab at a dose of 5mg/kg (as per patient weight) given at week 0, 2, 6 and 14
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, United Kingdom
Ultrasound Synovitis Score
reduction of ultrasound synovitis score of the affected knee at 8 weeks following intiation of treatment
Time frame: 8 weeks
US Synovitis Score
Change in US synovitis score of the affected knee at 2 and 8 weeks after treatment initiation
Time frame: 2 weeks
Pain Visual Analogue Scale
Change in patient's assessment of pain by a 100mm visual analogue score
Time frame: 2 weeks
Psoriatic Arthritis Quality of Life Scale (PsQOL)
Change in PsQOL score from baseline
Time frame: 2 weeks
Rheumatoid Arthritis Outcome Score (RAOS)
Change in RAOS questionnaire score
Time frame: 2 weeks
US Synovitis Score
Change in US synovitis score of the affected knee at 2 and 8 weeks after treatment initiation
Time frame: 16 weeks
Pain Visual Analogue Scale
Change in patient's assessment of pain by a 100mm visual analogue score
Time frame: 6 weeks
Pain Visual Analogue Scale
Change in patient's assessment of pain by a 100mm visual analogue score
Time frame: 8 weeks
Pain Visual Analogue Scale
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Change in patient's assessment of pain by a 100mm visual analogue score
Time frame: 14 weeks
Pain Visual Analogue Scale
Change in patient's assessment of pain by a 100mm visual analogue score
Time frame: 16 weeks
Psoriatic Arthritis Quality of Life Scale (PsQOL)
Change in PsQOL score from baseline
Time frame: 26 weeks
Psoriatic Arthritis Quality of Life Scale (PsQOL)
Change in PsQOL score from baseline
Time frame: 6 weeks
Psoriatic Arthritis Quality of Life Scale (PsQOL)
Change in PsQOL score from baseline
Time frame: 8 weeks
Psoriatic Arthritis Quality of Life Scale (PsQOL)
Change in PsQOL score from baseline
Time frame: 14 weeks
Psoriatic Arthritis Quality of Life Scale (PsQOL)
Change in PsQOL score from baseline
Time frame: 16 weeks
Rheumatoid Arthritis Outcome Score (RAOS)
Change in RAOS questionnaire score
Time frame: 6 weeks
Rheumatoid Arthritis Outcome Score (RAOS)
Change in RAOS questionnaire score
Time frame: 8 weeks
Rheumatoid Arthritis Outcome Score (RAOS)
Change in RAOS questionnaire score
Time frame: 14 weeks
Rheumatoid Arthritis Outcome Score (RAOS)
Change in RAOS questionnaire score
Time frame: 16 weeks
Rheumatoid Arthritis Outcome Score (RAOS)
Change in RAOS questionnaire score
Time frame: 26 weeks