osteoarthritis of the hand
Conditions
Interventions
Trade Name: Kineret
Product Name: Anakinra
Product Code: not applicable
Pharmaceutical Form: Injection
INN or Proposed INN: ANAKINRA
CAS Number: 143090-92-0
Current Sponsor code: na
Other descriptive
Sponsors
Universitätsklinik für Innere Medizin III, Klinische Abteilung für Rheumatologie, Medizinische Universität Wien
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject will be eligible for study participation if he/she meets the following criteria: • Males and females > 18 years of age. All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study. • Persistent or transient pain/aching at more than 3 days a week in at least one DIP and/or PIP joint with or without bony swelling • Hand X-ray showing alterations typical for OA • If NSAIDs are used to treat finger joint pain dosage must be stable for at least 4 weeks • Able and willing to give written informed consent and to comply with the requirements of the study protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: A subject will be excluded from the study if he/she meets any of the following criteria: • Prior treatment with any investigational agent within 30 days, or five half lives of the product, whichever is longer. • Patients suffering from chronic inflammatory rheumatic disease (e.g. rheumatoid arthritis or positive rheumatoid factor or positive anti-CCP antibodies, seronegative spondylarthropathy, haemochromatosis, gout, chondrocalcinosis or other auto-immune diseases • Stable dosage for at least 3 months with chondroitin sulfate, glucosamine, biphosphonate, tetracyclines and estrogens is allowed. • Prior use of any immunomodulating drug with possible effects on pro-inflammatory cytokine metabolism within 90 days a.o. corticosteroids, methotrexate, sulfasalazine, leflunomide, d-penicillamin, anti-malarials, cytotoxic drugs, TNF blocking agents • If the patient is of child-bearing age, she must use effective means of contraception during the study. • Use of anticoagulants (cumarins or low-molecular-weight-heparins) • Subjects with hand OA showing or having suffered from transient inflammatory attacks of the IPJs characteristic for what has been termed ‘inflammatory’ or ‘erosive’ hand OA. • Patient who has a known blood coagulation disorder • History of cancer or lymphoproliferative disease • Comorbidities: uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure (NYHA III, IV), recent stroke (within three months), uncontrolled hypertension (defined as screening systolic blood pressure > 160 mmHg or screening diastolic blood pressure > 100 mmHg), severe pulmonary disease requiring hospitalization or supplemental oxygen • Impaired renal function (CL Cr <30 ml/minute) • Persistent or recurrent infections or severe infections requiring hospitalization or treatment with iv antibiotics within 30 days, or oral antibiotics within 14 days prior to enrollment. • Female subjects who are breast-feeding. • History of clinically significant drug or alcohol abuse in the last year. • Medical history of systemic lupus erythematosus or other connective tissue disease, RA, reactive arthritis, psoriasis • Reasonable expectation that the subject will not be able to satisfactorily complete the study. History of or current psychiatric illness, alcohol or drug abuse that would interfere with the subject’s ability to comply with protocol requirements or give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Clinical trials have now generated optimism for anti-IL-1ß therapy as a new strategy in OA treatment. Nevertheless, there is an absolute lack in scientific evidence for the efficacy of IL-1beta inhibition in symptomatic non-erosive hand OA, thus, we aim to investigate the efficacy of a treatment with Anakinra 100 mg i.a. every four weeks during 24 weeks versus placebo as a therapeutic intervention in non-erosive symptomatic IPJ OA.;Secondary Objective: Not applicable;Primary end point(s): improvement of joint pain;Timepoint(s) of evaluation of this end point: every visit (Week-2,0,2,4,8,12,16,20,24,52) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): structure modifying effects as determined by MRI scan improvement of specific and generic physical function and joint stiffness improvement of patient global assessment ;Timepoint(s) of evaluation of this end point: structure modifying effects as determined by MRI scan: week-2 and week 52 improvement of specific and generic physical function and joint stiffness: Week-2,0,2,4,8,12,16,20,24,52 improvement of patient global assessment: Week-2,0,2,4,8,12,16,20,24,52 | — |
Countries
Austria
Contacts
Public ContactClinical Trials Information
Universitätsklinik für Innere Medizin III, Klinische Abteilung für Rheumatologie, Medizinische Universität Wien
Outcome results
None listed