Osteoarthritis MedDRA version: 9.1 Level: LLT Classification code 10023476 Term: Knee osteoarthritis
Conditions
Interventions
Product Code: SD-6010/ PHA-728669F
Pharmaceutical Form: Tablet
CAS Number: 753491-31-5
Current Sponsor code: SD-6010 / PHA-728669F
Other descriptive name: (R)-3-[(2-Acetimidamidoethyl)sulfanyl]-2-amin
Sponsors
Pfizer Inc, 235 East 42nd Street, New York, NY 10017
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Has provided written informed consent and is willing to comply with scheduled visits, treatment plan, radiographs, laboratory tests, and other trial procedures; 2. Is a female aged =40 years with a BMI =30 and the medial minimum JSW in the study knee; 5. No radiological findings such as, but not limited to avascular necrosis, fracture, infection, gout, Paget’s disease, osteopetrosis, osteochondritis, or other pathologies in the study knee. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects must meet all of the following Investigator Level inclusion criteria to advance to the knee imaging phase of Screen 1. Failure to meet these criteria will result in a Screen Fail for the subject Subjects presenting with any of the following will not be eligible for knee imaging at the Radiology Center. A “yes” response to any criterion below will result in a Screen Fail for the subject: 1. Subjects with a history of: A diagnosis of any other rheumatic disease Current, severe, uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, neurological disease, or any other condition which would make the subject unsuitable for the study within 6 months preceding the Screen 1 visit. Clinically significant infections (acute infection or those requiring hospitalization or visit; An active malignancy of any type or history of a malignancy Any known diseases or conditions that may involve the knees Significant trauma to the knees (including arthroscopy or significant injury to ligaments or menisci of the knee within 1 year preceding the Screen 1 visit 2. Subjects presenting with: A verified systolic blood pressure >150 mm Hg (if untreated for hypertension) or greater than 160 mm Hg (if treated for hypertension) and/or a diastolic blood pressure greater than 90 mm Hg; An ECG finding considered by the Investigator to be clinically significant; Any morbidities that would curtail work-related or leisure time physical activities such that these morbidities would contribute to increases in sedentary behaviors; Chronic potent opioid use; Any condition possibly affecting oral drug absorption; Anticipated need for knee or hip surgery in the next 2 years; Exacerbation of OA pain in either knee requiring a change in stable treatment within 4 weeks of the Screen 1 visit; Symptomatic OA of either hip by history or elicited on physical examination that may confound the interpretation of knee pain; Clinically significant non-articular musculoskeletal pain that cannot be distinguished from knee OA; Intra-articular hyaluronic acid to either knee within 6 months preceding the Screen 1 visit; Use of any investigational drug within 1 month preceding the Screen 1 visit; 3. Pregnant or breastfeeding females; 4. Anticipating a move out of the area of the clinic in the next 2 years. 5. A subject anticipating or participating in a defined weight loss program for any reason in the next 2 years. Exclusion Criteria at Screen 2 Subjects advancing to Screen 2 will have successfully completed the cursory review of safety, have passed the Investigator Level inclusion/exclusion tests of Screen 1, and have been successfully screened by the Central Reader and the Central Imaging Core Laboratory. The Screen 2 visit will essentially complete all other safety screens for eligibility and establish the baseline values for safety and for the majority of secondary efficacy assessments. Subjects presenting with any of the following will not qualify for randomization. Failure to meet these criteria will result in a Screen Fail for the subject: 1. Clinical signs of tuberculosis (TB) such as generalized tiredness or weakness, weight loss, fever, night sweats, coughing, chest pain, coughing up sputum and/or blood, shortness of breath, x-ray showing infiltrates or fibrosis suggestive of TB; 2. Currently undergoing treatment for TB; 3. Evidence of latent TB infection (LTBI) without documented evidence of treatment with an acceptable c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the disease modifying efficacy of SD-6010 50 mg and 200 mg QD compared to placebo in reducing the rate of progression of OA as assessed by radiographic JSN in the medial tibiofemoral compartment of the study knee of obese women with knee OA.;Secondary Objective: 1. To assess the safety and tolerability of SD-6010 50 mg and 200 mg QD administered long-term to obese women with knee OA; 2.To assess the clinical benefit of SD-6010 50 mg and 200 mg QD in obese women with knee OA as measured by the clinical endpoints including, but not limited to, WOMAC, pain VAS (visual analog scale), changes in background pain therapy and use of rescue medication in the study knee.;Primary end point(s): The progression rate of Joint space narrowing (JSN) | — |
Countries
Belgium, Czech Republic, Germany, Hungary, Italy, Slovakia, Spain
Outcome results
None listed