SpondylarthropathiesPhase 2SOKSNCT01216631
Seronegative Oligoarthritis of the Knee Study (SOKS)
A Phase 2 study testing methylprednisolone and Infliximab in people with Spondylarthropathies, run by University of Leeds at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondylarthropathies
- What is being tested?
- methylprednisolone and Infliximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2010to Aug 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, LS7 4SA
About this study
Official title: Intra-articular and Intravenous Infliximab in the Treatment of Resistant Seronegative Oligoarthritis of the Knee
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.
- Conditions
- Spondylarthropathies
- Being tested
- methylprednisolone, Infliximab
- Keywords
- seronegative, oligoarthritis, infliximab, intraarticular
- Medical subject headings
- Spondylarthropathies, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called depomedrone
intra-articular injection of methylprednisolone (80mg given at baseline only)
InfliximabDrug
Also called remicade
intra-articular injection of 100mg infliximab given at baseline only
InfliximabDrug
Also called remicade
intravenous infliximab at a dose of 5mg/kg (as per patient weight) given at week 0, 2, 6 and 14
| Study group | Role | What they receive |
|---|---|---|
| IA steroid | Active comparator | Intra-articular injection of steroid (80mg depomedrone) Receives: Drug: methylprednisolone |
| IA infliximab | Experimental | intra-articular injection of 100mg infliximab Receives: Drug: Infliximab |
| IV infliximab | Experimental | intravenous infusions of infliximab given at 0, 2, 6 and 14 weeks at a dose of 5mg/kg (patient body weight) Receives: Drug: Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound Synovitis Score
reduction of ultrasound synovitis score of the affected knee at 8 weeks following intiation of treatment
Measured: 8 weeks
Secondary outcomes (19)
US Synovitis Score
Change in US synovitis score of the affected knee at 2 and 8 weeks after treatment initiation
Measured: 2 weeks
Pain Visual Analogue Scale
Change in patient's assessment of pain by a 100mm visual analogue score
Measured: 2 weeks
Psoriatic Arthritis Quality of Life Scale (PsQOL)
Change in PsQOL score from baseline
Measured: 2 weeks
Rheumatoid Arthritis Outcome Score (RAOS)
Change in RAOS questionnaire score
Measured: 2 weeks
US Synovitis Score
Change in US synovitis score of the affected knee at 2 and 8 weeks after treatment initiation
Measured: 16 weeks
Pain Visual Analogue Scale
Change in patient's assessment of pain by a 100mm visual analogue score
Measured: 6 weeks
Pain Visual Analogue Scale
Change in patient's assessment of pain by a 100mm visual analogue score
Measured: 8 weeks
Pain Visual Analogue Scale
Change in patient's assessment of pain by a 100mm visual analogue score
Measured: 14 weeks
Pain Visual Analogue Scale
Change in patient's assessment of pain by a 100mm visual analogue score
Measured: 16 weeks
Psoriatic Arthritis Quality of Life Scale (PsQOL)
Change in PsQOL score from baseline
Measured: 26 weeks
Psoriatic Arthritis Quality of Life Scale (PsQOL)
Change in PsQOL score from baseline
Measured: 6 weeks
Psoriatic Arthritis Quality of Life Scale (PsQOL)
Change in PsQOL score from baseline
Measured: 8 weeks
Psoriatic Arthritis Quality of Life Scale (PsQOL)
Change in PsQOL score from baseline
Measured: 14 weeks
Psoriatic Arthritis Quality of Life Scale (PsQOL)
Change in PsQOL score from baseline
Measured: 16 weeks
Rheumatoid Arthritis Outcome Score (RAOS)
Change in RAOS questionnaire score
Measured: 6 weeks
Rheumatoid Arthritis Outcome Score (RAOS)
Change in RAOS questionnaire score
Measured: 8 weeks
Rheumatoid Arthritis Outcome Score (RAOS)
Change in RAOS questionnaire score
Measured: 14 weeks
Rheumatoid Arthritis Outcome Score (RAOS)
Change in RAOS questionnaire score
Measured: 16 weeks
Rheumatoid Arthritis Outcome Score (RAOS)
Change in RAOS questionnaire score
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionAug 2011
- Study completionAug 2011
Why it stopped: Unable to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SpondylarthropathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- Centocor, Inc.
- Responsible party
- Principal investigator, Laura Coates, University of Leeds
- Investigators
- Philip G Conaghan, FRCP, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216631
- Sponsor's protocol ID
- 2009-015810-23
- Other IDs
- 2009
- Acronym
- SOKS
- Status last verified
- May 2016
- First submitted
- 6 Oct 2010
- Last updated
- 13 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-articular and Intravenous Infliximab in the Treatment of Resistant Seronegative Oligoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT01216631
- Acronym / sponsor ID
- SOKS / 2009-015810-23
- Conditions
- Spondylarthropathies
- Keywords
- seronegative, oligoarthritis, infliximab, intraarticular
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- Centocor, Inc.
- Study start
- Sep 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 7 Oct 2010 (estimated)
- Results
- Posted 13 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IA steroid | Active comparator | Drug: methylprednisoloneIntra-articular injection of steroid (80mg depomedrone) |
| IA infliximab | Experimental | Drug: Infliximabintra-articular injection of 100mg infliximab |
| IV infliximab | Experimental | Drug: Infliximabintravenous infusions of infliximab given at 0, 2, 6 and 14 weeks at a dose of 5mg/kg (patient body weight) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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.
Key exclusion criteria (24 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methylprednisoloneAlso: depomedroneintra-articular injection of methylprednisolone (80mg given at baseline only) | Drug | IA steroid |
| InfliximabAlso: remicadeintra-articular injection of 100mg infliximab given at baseline only | Drug | IA infliximab |
| InfliximabAlso: remicadeintravenous infliximab at a dose of 5mg/kg (as per patient weight) given at week 0, 2, 6 and 14 | Drug | IV infliximab |
Primary outcome
Ultrasound Synovitis Score
Time frame: 8 weeks
reduction of ultrasound synovitis score of the affected knee at 8 weeks following intiation of treatment
19 secondary outcomes
US Synovitis Score
Time frame: 2 weeks
Pain Visual Analogue Scale
Time frame: 2 weeks
Psoriatic Arthritis Quality of Life Scale (PsQOL)
Time frame: 2 weeks
Rheumatoid Arthritis Outcome Score (RAOS)
Time frame: 2 weeks
US Synovitis Score
Time frame: 16 weeks
Pain Visual Analogue Scale
Time frame: 6 weeks
Pain Visual Analogue Scale
Time frame: 8 weeks
Pain Visual Analogue Scale
Time frame: 14 weeks
Pain Visual Analogue Scale
Time frame: 16 weeks
Psoriatic Arthritis Quality of Life Scale (PsQOL)
Time frame: 26 weeks
Psoriatic Arthritis Quality of Life Scale (PsQOL)
Time frame: 6 weeks
Psoriatic Arthritis Quality of Life Scale (PsQOL)
Time frame: 8 weeks
Psoriatic Arthritis Quality of Life Scale (PsQOL)
Time frame: 14 weeks
Psoriatic Arthritis Quality of Life Scale (PsQOL)
Time frame: 16 weeks
Rheumatoid Arthritis Outcome Score (RAOS)
Time frame: 6 weeks
Rheumatoid Arthritis Outcome Score (RAOS)
Time frame: 8 weeks
Rheumatoid Arthritis Outcome Score (RAOS)
Time frame: 14 weeks
Rheumatoid Arthritis Outcome Score (RAOS)
Time frame: 16 weeks
Rheumatoid Arthritis Outcome Score (RAOS)
Time frame: 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip G Conaghan, FRCP principal investigator
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing methylprednisolone and Infliximab in people with Spondylarthropathies, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound Synovitis Score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.