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Health Condition(s) or Problem
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Spondylarthropathies
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Lay Summary
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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.
(from ClinicalTrials.gov)
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Who can enter the trial
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Inclusion Criteria:
- Inflammatory oligoarthritis (4 or less active joints) with at least one swollen knee
joint of at least 3 months duration
- Rheumatoid factor and anti-CCP Ab negative
- Either arthritis onset at <45 years of age, or arthritis onset at =45 years of age
with early morning stiffness>30mins or raised inflammatory markers
- If under 40 years of age, clinical exclusion of a diagnosis of gout.
- If 40 years or older at screening, a prior normal examination of synovial fluid from
the affected joint excluding crystal arthropathy or infection.
- Failure of methotrexate (inefficacy after >3 month trial, intolerance or
contra-indication)
- Have the capacity to understand and sign an informed consent form.
- Gender: male or female
- 18 years of age or over.
- Women must be either postmenopausal (no menstrual period for a minimum of 1 year) or
surgically sterilized or in use of adequate birth control measures and have a
negative serum pregnancy test on entry in the study.
- Men and women of childbearing potential must use adequate birth control measures
(e.g., abstinence, oral contraceptives, intrauterine device, barrier method with
spermicide, implantable or injectable contraceptives or surgical sterilization) for
the duration of the study and should continue such precautions for 6 months after
receiving the last infusion.
- Are considered eligible according to the tuberculosis (TB) eligibility assessment,
screening, and early detection of reactivation rules defined in the protocol
- The screening laboratory test results must meet the following criteria
- WBC (white blood cell count): >3.5 x 109/L
- ANC (absolute neutrophil count): >1.5 x 109/L
- Hemoglobin: >10g/dL
- Platelets: >120 x 109/L
- SGPT (ALT - alanine aminotransferase) < 1.5 times upper normal limit (i.e.
60iu/L)
- Have no history of latent or active TB prior to screening. An exception is made for
subjects with a history of latent TB and documentation of having completed
appropriate treatment for latent TB (see Appendix 3) within 3 years prior to the
first administration of study agent. It is the responsibility of the investigator to
verify the adequacy of previous anti-tuberculous treatment and provide appropriate
documentation.
- Have no signs or symptoms suggestive of active TB upon medical history and/or
physical examination.
- Have had no recent close contact with a person with active TB or, if there has been
such contact, will be referred to a physician specializing in TB to undergo
additional evaluation and, if warranted, receive appropriate treatment for latent TB
prior to the first administration of study agent.
- Within 6 weeks prior to the first administration of study agent, either have a
negative QuantiFeron test result (see Appendix 3) or have a newly identified positive
QuantiFeron test result during screening in which active TB has been ruled out and
for which appropriate treatment for latent TB has been initiated prior to the first
administration of study agent.
- Have a chest radiograph (posterior-anterior view and if required, a lateral view),
taken within 3 months prior to the first administration of study agent and read by a
qualified radiologist, with no evidence of current, active TB or old, inactive TB.
Exclusion Criteria:
- Grade 4 osteoarthritis (Ke
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Who cannot enter the trial
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Inclusion Criteria:
- Inflammatory oligoarthritis (4 or less active joints) with at least one swollen knee
joint of at least 3 months duration
- Rheumatoid factor and anti-CCP Ab negative
- Either arthritis onset at <45 years of age, or arthritis onset at =45 years of age
with early morning stiffness>30mins or raised inflammatory markers
- If under 40 years of age, clinical exclusion of a diagnosis of gout.
- If 40 years or older at screening, a prior normal examination of synovial fluid from
the affected joint excluding crystal arthropathy or infection.
- Failure of methotrexate (inefficacy after >3 month trial, intolerance or
contra-indication)
- Have the capacity to understand and sign an informed consent form.
- Gender: male or female
- 18 years of age or over.
- Women must be either postmenopausal (no menstrual period for a minimum of 1 year) or
surgically sterilized or in use of adequate birth control measures and have a
negative serum pregnancy test on entry in the study.
- Men and women of childbearing potential must use adequate birth control measures
(e.g., abstinence, oral contraceptives, intrauterine device, barrier method with
spermicide, implantable or injectable contraceptives or surgical sterilization) for
the duration of the study and should continue such precautions for 6 months after
receiving the last infusion.
- Are considered eligible according to the tuberculosis (TB) eligibility assessment,
screening, and early detection of reactivation rules defined in the protocol
- The screening laboratory test results must meet the following criteria
- WBC (white blood cell count): >3.5 x 109/L
- ANC (absolute neutrophil count): >1.5 x 109/L
- Hemoglobin: >10g/dL
- Platelets: >120 x 109/L
- SGPT (ALT - alanine aminotransferase) < 1.5 times upper normal limit (i.e.
60iu/L)
- Have no history of latent or active TB prior to screening. An exception is made for
subjects with a history of latent TB and documentation of having completed
appropriate treatment for latent TB (see Appendix 3) within 3 years prior to the
first administration of study agent. It is the responsibility of the investigator to
verify the adequacy of previous anti-tuberculous treatment and provide appropriate
documentation.
- Have no signs or symptoms suggestive of active TB upon medical history and/or
physical examination.
- Have had no recent close contact with a person with active TB or, if there has been
such contact, will be referred to a physician specializing in TB to undergo
additional evaluation and, if warranted, receive appropriate treatment for latent TB
prior to the first administration of study agent.
- Within 6 weeks prior to the first administration of study agent, either have a
negative QuantiFeron test result (see Appendix 3) or have a newly identified positive
QuantiFeron test result during screening in which active TB has been ruled out and
for which appropriate treatment for latent TB has been initiated prior to the first
administration of study agent.
- Have a chest radiograph (posterior-anterior view and if required, a lateral view),
taken within 3 months prior to the first administration of study agent and read by a
qualified radiologist, with no evidence of current, active TB or old, inactive TB.
Exclusion Criteria:
- Grade 4 osteoarthritis (Ke
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What will happen
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Drug; methylprednisolone; intra-articular injection of methylprednisolone (80mg given at baseline only); IA steroid; depomedrone; Drug; Infliximab; intra-articular injection of 100mg infliximab given at baseline only; IA infliximab; remicade; Drug; Infliximab; intravenous infliximab at a dose of 5mg/kg (as per patient weight) given at week 0, 2, 6 and 14; IV infliximab; remicade
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Primary aim
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Ultrasound synovitis score
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Secondary Aim
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US synovitis score; 2 weeks; No; Change in US synovitis score of the affected knee at 2 and 8 weeks after treatment initiation; Pain visual analogue scale; 2 weeks; No; Change in patient's assessment of pain by a 100mm visual analogue score; Psoriatic Arthritis Quality of Life Scale (PsQOL); 2 weeks; No; Change in PsQOL score from baseline; Rheumatoid Arthritis Outcome Score (RAOS); 2 weeks; No; Change in RAOS questionnaire score; US synovitis score; 16 weeks; No; Change in US synovitis score of the affected knee at 2 and 8 weeks after treatment initiation; Pain visual analogue scale; 6 weeks; No; Change in patient's assessment of pain by a 100mm visual analogue score; Pain visual analogue scale; 8 weeks; No; Change in patient's assessment of pain by a 100mm visual analogue score; Pain visual analogue scale; 14 weeks; No; Change in patient's assessment of pain by a 100mm visual analogue score; Pain visual analogue scale; 16 weeks; No; Change in patient's assessment of pain by a 100mm visual analogue score; Psoriatic Arthritis Quality of Life Scale (PsQOL); 26 weeks; No; Change in PsQOL score from baseline; Psoriatic Arthritis Quality of Life Scale (PsQOL); 6 weeks; No; Change in PsQOL score from baseline; Psoriatic Arthritis Quality of Life Scale (PsQOL); 8 weeks; No; Change in PsQOL score from baseline; Psoriatic Arthritis Quality of Life Scale (PsQOL); 14 weeks; No; Change in PsQOL score from baseline; Psoriatic Arthritis Quality of Life Scale (PsQOL); 16 weeks; No; Change in PsQOL score from baseline; Rheumatoid Arthritis Outcome Score (RAOS); 6 weeks; No; Change in RAOS questionnaire score; Rheumatoid Arthritis Outcome Score (RAOS); 8 weeks; No; Change in RAOS questionnaire score; Rheumatoid Arthritis Outcome Score (RAOS); 14 weeks; No; Change in RAOS questionnaire score; Rheumatoid Arthritis Outcome Score (RAOS); 16 weeks; No; Change in RAOS questionnaire score; Rheumatoid Arthritis Outcome Score (RAOS); 26 weeks; No; Change in RAOS questionnaire score
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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Leeds
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