Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Alflutop: 1 mL once a day, Intramuscularly for 20 days
Control Intervention1: Standard of Care :- Meloxicam or Paracetamol: 5oomg twice a day, orally for 20 days (in judgment of Investi
Sponsors
Biotehnos Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Signed Patient Information Sheet and Informed Consent Form to participate in the study. 2. Men and women aged 40 to 75 years (inclusive). 3. Diagnosis of osteoarthritis of the knee joint established in accordance with the classification criteria of the American College of Rheumatology (ACR) and with X-ray signs of grade II or III according to the Kellgren-Lawrence classification. 4. Pain during walking in target knee joint according to VAS > 40 mm (moderate or severe pain when walking). Patients with bilateral osteoarthritis of knee joints can be included in the study, but data on efficacy and safety must be collected for the most painful knee joint (target knee). According to VAS, the level of pain in the contralateral knee joint must be less than in the target knee joint ( 5. Need of daily/ long-term use of NSAIDs (at least 30 days) over the past three months. 6. Consent of patients, including men and women with childbearing potential (who have not undergone surgical sterilization or who have been in menopause less than 2 years), to use adequate contraception methods during the entire study and 3 months after the end of therapy. Adequate contraceptive methods include a condom or diaphragm
Exclusion criteria
Exclusion criteria: 1. Concomitant inflammatory disease or other condition that affects the joints (e.g. rheumatoid arthritis, metabolic bone disease, psoriasis, gout, symptomatic chondrocalcinosis etc.) 2. Significant (requiring surgical treatment) valgus or varus deformity of the knee joint, ligamentous laxity, or destruction of the meniscus. 3. Concomitant osteoarthritis of the hip and/or ankle joints, of severe grade, which may make it difficult to assess the effectiveness or pain in the knee joint. 4. History of septic arthritis of any joint or suspected subacute infectious inflammation in the target joint. 5. Surgical treatment of a targeted knee in history. 6. Planned surgery on any joint of the lower extremities during the study. 7. Lymphovenous insufficiency of the lower limbs, grade III. 8. Diseases and concomitant conditions affecting the structure and density of bone tissue (hyperparathyroid osteodystrophy, malabsorption syndrome, osteomalacia, osteogenesis imperfecta, etc.). 9. The following abnormalities of laboratory parameters: Complete blood count: Hemoglobin: Liver function: Total bilirubin: >2.0 Ã?â?? UNL AST or ALT: >2.5 Ã?â?? UNL Kidney function: GFR (Cockcroft-Gault formula): 10. Current or 12 months prior to screening severe cardiovascular diseases, including: NYHA Class III or IV chronic heart failure, clinically significant ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation), unstable angina, myocardial infarction, heart and coronary vessel surgery, significant valvular heart disease, uncontrolled arterial hypertension with systolic blood pressure >180 mm Hg and diastolic blood pressure >110 mm Hg, pulmonary embolism or deep vein thrombosis. 11. Type 1 diabetes mellitus and uncontrolled type 2 diabetes mellitus (HbA1c > 10.5 %, fasting plasma glucose >270 mg/dl at screening or episodes of severe hypoglycemia 1 month prior to screening); 12. Subjects with BMI ââ?°Â¥ 40 kg/m2 13. Severe diseases of the central nervous system, including seizures in history or conditions that may lead to their development; stroke or transient ischemic attack within 12 months prior to screening; head injuries or loss of consciousness within 12 months prior to screening; a brain tumor. 14. Diseases manifested by increased bleeding (hemorrhagic diathesis, hemophilia, thrombocytopenia, etc.), or conditions with a high risk of bleeding. 15. Significant uncontrolled concomitant disease, such as neurological, renal, hepatic, endocrine and gastrointestinal which according to the Investigator, could prevent the patient from participating in the study. 16. Participation in other clinical studies or administration of investigational products within 4 weeks prior to screening. 17. HIV, active viral (hepatitis B and C) or a cirrhotic liver disease in medical history. 18. Malignancies within the last 5 years (except for basal cell carcinoma of the skin and cervical cancer in situ that had undergone surgical removal or treatment). 19. Drug or alcohol abuse at the time of screening or in the past which, in the opinion of the Investigator, makes the patient un
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the efficacy of AlflutopÃ?® therapy in standard regimen (1 mL i/m daily for 20 days) based on change in the WOMAC (pain) scale on Week 8 compared to baseline (Week 0) in patients with osteoarthritis of knee joints in Indian population.Timepoint: Week 0 to Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in WOMAC scores (pain, stiffness, function). ââ?¬Â¢ Efficacy evaluation based on OMERACT-OARSI responder criteria (in correspondence to T. Pham 2004). ââ?¬Â¢ Change in the score according to the EQ-5D Health Questionnaire. ââ?¬Â¢ Change in the score according to the Patientââ?¬â?¢s Global Assessment scale. ââ?¬Â¢ Change in the score according to the Investigatorââ?¬â?¢s Global Assessment scale. ââ?¬Â¢ Change in the score according to the Patientââ?¬â?¢s Global Pain Assessment according to VAS scale. ââ?¬Â¢ Number of days without analgetic concomitant therapy and change in concomitant medication daily dose (meloxicam or paracetamol). ââ?¬Â¢ Incidence of adverse events (AE) of various severities and serious adverse events (SAE) on the basis of subjects complaints, laboratory tests, physical examination, vital sign examination and electrocardiography (ECG).Timepoint: Week 0 to Week 8 | — |
Countries
India
Contacts
Public ContactDr Devesh Kumar
CliniExperts Research Services Private Limited
Outcome results
None listed