Seronegative Oligoarthritis of the Knee Study (SOKS) | Recruiting
Seronegative Oligoarthritis of the Knee Study (SOKS)
SOKS
Trial Source

Health Conditions
  • Spondylarthropathies
Recruiting
Recruitment Status
NCT01216631
Primary Trial ID Number
Summary
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.
Primary Outcome Measures
  • Ultrasound synovitis score; 8 weeks
Secondary Outcome Measures
  • US synovitis score; 2 weeks; Pain visual analogue scale; 2 weeks; Psoriatic Arthritis Quality of Life Scale (PsQOL); 2 weeks; Rheumatoid Arthritis Outcome Score (RAOS); 2 weeks; US synovitis score; 16 weeks; Pain visual analogue scale; 6 weeks; Pain visual analogue scale; 8 weeks; Pain visual analogue scale; 14 weeks; Pain visual analogue scale; 16 weeks; Psoriatic Arthritis Quality of Life Scale (PsQOL); 26 weeks; Psoriatic Arthritis Quality of Life Scale (PsQOL); 6 weeks; Psoriatic Arthritis Quality of Life Scale (PsQOL); 8 weeks; Psoriatic Arthritis Quality of Life Scale (PsQOL); 14 weeks; Psoriatic Arthritis Quality of Life Scale (PsQOL); 16 weeks; Rheumatoid Arthritis Outcome Score (RAOS); 6 weeks; Rheumatoid Arthritis Outcome Score (RAOS); 8 weeks; Rheumatoid Arthritis Outcome Score (RAOS); 14 weeks; Rheumatoid Arthritis Outcome Score (RAOS); 16 weeks; Rheumatoid Arthritis Outcome Score (RAOS); 26 weeks
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
Sorry, this information is not available
Publications
Sorry, this information is not available
Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
30
Participant Inclusion Criteria
  • 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 (Kellgren-Lawrence score) on plain radiograph of the knee
  • - Rheumatoid Arthritis (defined by the ACR criteria for the diagnosis of RA, 1987)
  • - Ankylosing Spondylitis (defined by the modified New York Criteria)
  • - Clinical diagnosis of gout or previous evidence of crystal arthropathy on synovial
  • fluid aspirates
  • - Women who are pregnant, nursing, or planning pregnancy within 6 months after the last
  • infusion (this includes father's who plan on fathering a child within 6 months after
  • their last infusion).
  • - Have had any previous treatment with biological therapies.
  • - History of receiving human/murine recombinant products or a known allergy to murine
  • products. A known allergy to murine product is definitely an exclusion criterion
  • - Previous intra-muscular, intra-articular or intra-venous steroids within 4 weeks
  • prior to baseline.
  • - Previous oral steroids at a dose >10mg/day prednisolone or equivalent for 4 weeks
  • prior to baseline.
  • - Documentation of seropositive for human immunodeficiency virus (HIV).
  • - Documentation of a positive test for hepatitis B surface antigen or hepatitis C.
  • - Have a history of alcohol or substance abuse within the preceding 6 months that, in
  • the opinion of the investigator, may increase the risks associated with study
  • participation or study agent administration, or may interfere with interpretation of
  • results.
  • - Have a known history of serious infections (e.g., hepatitis, pneumonia, or
  • pyelonephritis) in the previous 3 months.
  • - Have or have had an opportunistic infection (e.g., herpes zoster [shingles],
  • cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria
  • other than TB) within 6 months prior to screening
  • - Have had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of screening.
  • - Are considered ineligible according to the TB eligibility assessment, screening, and
  • early detection of reactivation rules described in Appendix 3.
  • - Have a chest radiograph within 3 months prior to the first administration of study
  • agent that shows an abnormality suggestive of a malignancy or current active
  • infection.
  • - Have a history of lymphoproliferative disease, including lymphoma or signs suggestive
  • of possible lymphoproliferative disease such as lymphadenopathy of unusual size or
  • location (e.g., nodes in the posterior triangle of the neck, infraclavicular,
  • epitrochlear, or periaortic area), or splenomegaly.
  • - Currently have any known malignancy other than the condition being treated or have a
  • history of malignancy, with the exception of basal cell or squamous cell carcinoma of
  • the skin that has been fully excised with no evidence of recurrence.
  • - Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic,
  • hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral
  • disease.
  • - Are unable or unwilling to undergo multiple venipunctures because of poor
  • tolerability or lack of easy access.
  • - Use of any investigational drug within 30 days prior to screening or within 5
  • half-lives of the investigational agent, whichever is longer.
  • - Presence of a transplanted solid organ (with the exception of a corneal transplant >
  • 3 months prior to screening).
  • - Have a concomitant diagnosis or history of congestive heart failure.
Participant Exclusion Criteria
  • 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 (Kellgren-Lawrence score) on plain radiograph of the knee
  • - Rheumatoid Arthritis (defined by the ACR criteria for the diagnosis of RA, 1987)
  • - Ankylosing Spondylitis (defined by the modified New York Criteria)
  • - Clinical diagnosis of gout or previous evidence of crystal arthropathy on synovial
  • fluid aspirates
  • - Women who are pregnant, nursing, or planning pregnancy within 6 months after the last
  • infusion (this includes father's who plan on fathering a child within 6 months after
  • their last infusion).
  • - Have had any previous treatment with biological therapies.
  • - History of receiving human/murine recombinant products or a known allergy to murine
  • products. A known allergy to murine product is definitely an exclusion criterion
  • - Previous intra-muscular, intra-articular or intra-venous steroids within 4 weeks
  • prior to baseline.
  • - Previous oral steroids at a dose >10mg/day prednisolone or equivalent for 4 weeks
  • prior to baseline.
  • - Documentation of seropositive for human immunodeficiency virus (HIV).
  • - Documentation of a positive test for hepatitis B surface antigen or hepatitis C.
  • - Have a history of alcohol or substance abuse within the preceding 6 months that, in
  • the opinion of the investigator, may increase the risks associated with study
  • participation or study agent administration, or may interfere with interpretation of
  • results.
  • - Have a known history of serious infections (e.g., hepatitis, pneumonia, or
  • pyelonephritis) in the previous 3 months.
  • - Have or have had an opportunistic infection (e.g., herpes zoster [shingles],
  • cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria
  • other than TB) within 6 months prior to screening
  • - Have had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of screening.
  • - Are considered ineligible according to the TB eligibility assessment, screening, and
  • early detection of reactivation rules described in Appendix 3.
  • - Have a chest radiograph within 3 months prior to the first administration of study
  • agent that shows an abnormality suggestive of a malignancy or current active
  • infection.
  • - Have a history of lymphoproliferative disease, including lymphoma or signs suggestive
  • of possible lymphoproliferative disease such as lymphadenopathy of unusual size or
  • location (e.g., nodes in the posterior triangle of the neck, infraclavicular,
  • epitrochlear, or periaortic area), or splenomegaly.
  • - Currently have any known malignancy other than the condition being treated or have a
  • history of malignancy, with the exception of basal cell or squamous cell carcinoma of
  • the skin that has been fully excised with no evidence of recurrence.
  • - Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic,
  • hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral
  • disease.
  • - Are unable or unwilling to undergo multiple venipunctures because of poor
  • tolerability or lack of easy access.
  • - Use of any investigational drug within 30 days prior to screening or within 5
  • half-lives of the investigational agent, whichever is longer.
  • - Presence of a transplanted solid organ (with the exception of a corneal transplant >
  • 3 months prior to screening).
  • - Have a concomitant diagnosis or history of congestive heart failure.
Interventions
Drug; methylprednisolone; intra-articular injection of methylprednisolone (80mg given at baseline only); [IA steroid]; Drug; Infliximab; intra-articular injection of 100mg infliximab given at baseline only; [IA infliximab]; Drug; Infliximab; intravenous infliximab at a dose of 5mg/kg (as per patient weight) given at week 0, 2, 6 and 14; [IV infliximab]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Results Reporting
Sorry, this information is not available
Acronym
SOKS
Scientific Title
Intra-articular and Intravenous Infliximab in the Treatment of Resistant Seronegative Oligoarthritis of the Knee
Secondary Trial Identifying Number
Sorry, this information is not available
Website
Sorry, this information is not available
Study Funded By
University of Leeds
Funder Type
Sorry, this information is not available
Study Sponsored By
University of Leeds
Study Also Sponsored By
Centocor, Inc.
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

06 Oct 2010

Last Updated

06 Oct 2010

Date Record Refreshed on UKCTG

31 Jul 2015