Seronegative Oligoarthritis of the Knee Study (SOKS)

NCT01216631 | Terminated Phase 2 Results DMC

• 1 other identifier: 2009-015810-23
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spondylarthropathies

Keywords

seronegative; oligoarthritis; infliximab; intraarticular

Outcome Measures

Primary Outcomes (1)

• Ultrasound Synovitis Score

  reduction of ultrasound synovitis score of the affected knee at 8 weeks following intiation of treatment

  8 weeks

Secondary Outcomes (19)

• 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

Study Arms (3)

IA steroid

ACTIVE COMPARATOR

Intra-articular injection of steroid (80mg depomedrone)

Drug: methylprednisolone

IA infliximab

EXPERIMENTAL

intra-articular injection of 100mg infliximab

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)

Drug: Infliximab

Interventions

methylprednisolone DRUG

intra-articular injection of methylprednisolone (80mg given at baseline only)

Also known as: depomedrone

IA steroid

Infliximab DRUG

intra-articular injection of 100mg infliximab given at baseline only

Also known as: remicade

IA infliximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Leeds: lead
• Centocor, Inc.: collaborator

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, LS7 4SA, United Kingdom

Location

MeSH Terms

Conditions

Spondylarthropathies; Arthritis

Interventions

Methylprednisolone; Infliximab

Condition Hierarchy (Ancestors)

Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Joint Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Professor Philip Conaghan
• Organization: University of Leeds

p.conaghan@leeds.ac.uk

+44 113 3924884

Study Officials

• Philip G Conaghan, FRCP

  University of Leeds

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: NIHR Clinical Lecturer

Study Record Dates

• First Submitted: October 6, 2010
• First Posted: October 7, 2010
• Study Start: September 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: May 13, 2016
• Results First Posted: May 13, 2016

Record last verified: 2016-05

Locations

GB (1)