Erosive / inflammatory arthrosis of the hands MedDRA version: 20.0 Level: LLT Classification code 10003416 Term: Arthrosis System Organ Class: 100000004859
Conditions
Interventions
Product Name: Montelukast sodium
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: MONTELUKAST SODIUM
CAS Number: 151767-02-1
Other descriptive name: MONTELUKAST SODIUM
Concentration unit: mg mi
Sponsors
Laboratorios Farmalíder S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who give their written informed consent and are willing to comply with all the visits and planned procedures required by the study 2. Patients = 18 years old at the time of the screening visit 3. Patients with erosive arthritis of the interphalangeal joints of the hand with significant clinical activity according to Anandarajah (Anandarajah, A. 2010) criteria 4. Patients with a pain = 50 mm in the VAS at the baseline visit 5. Patients with functional consequence despite the conventional treatment 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 196 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 84
Exclusion criteria
Exclusion criteria: Related to medical history 1. History of active malignant neoplasm of any type or with a history of malignant neoplasm in the last five years 2. History of fibromyalgia and/or chronic fatigue syndrome 3. History of myocardial infarction or stroke, or who have experienced chest pain related to a heart disease, or who have suffered from severe heart disease 4. History of concurrent rheumatic joint disease (history and/or current presence of signs) that could lead to misinterpretation or interfere with the assessment 5. Pain in other parts of the body that is more intense than the hand pain and that could interfere with the assessment and the study results. 6. Patients with poorly controlled AHT (maintained systolic blood pressure >150mm Hg or maintained diastolic blood pressure >95mm Hg) 7. Patients with poorly controlled diabetes mellitus, defined by a Hemoglobin A1c level >8% 8. History of immunosuppression 9. Hepatitis B surface antigen (HBsAg) test result or positive antibody to Hepatitis C 10. Patients with acute or chronic active infections requiring antimicrobial treatment or severe fungal or viral infections 11. Patients with a significant coagulation defect 12. Patients who have been diagnosed with esophageal, gastric, pyloric, or duodenal ulcers, or who have received treatment for them within 30 days prior to the screening visit 13. Patients with chronic liver disease defined by AST o ALT 2 times upper limit of normal 14. Patients with chronic kidney disease with blood urea nitrogen (BUN) or serum creatinine levels 2 times the ULN or Clcr<30 ml/minute at the screening visit 15. History of significant medical conditions, which in the opinion of the investigator, would exclude the patient from participating in this clinical trial Related to the investigational medicinal product 1. Patients taking corticosteroids (oral or injectable), methotrexate, hydroxychloroquine or SYDADOA (slow-acting drugs for the symptomatic treatment of osteoarthritis) in the 12 weeks prior to the screening visit 2. Patients who have used intra-articular hyaluronic acid (in the study hand) during the 24 weeks prior to the screening visit 3. Patients undergoing radioactive synoviorthesis (in the study hand) 4. Patients who have received any live virus vaccine during the 12 weeks prior to the screening visit (also not allowed during the clinical trial, including 3 months after the last dose of study medication) 5. Patients under treatment with other disease-modifying antirheumatic biologic drugs 6. Patients under treatment with oral anticoagulants 7. Patients under treatment with any other medication that should not be administered due to the risk of adverse interactions with the study medication listed in the protocol 8. Patients who have used paracetamol or other analgesics and/or NSAIDs during the 15 days prior to the start of study treatment 9. Patients with a history of allergy or hypersensitivity to the study medication, rescue medication or any of its excipients 10. Patients with intolerance to study medication due to galactose intolerance, lactase insufficiency or glucose or galactose malabsorption 11. Patients with a history of known hypersensitivity to sulfonamides 12. Active peptic ulcer, NSAID gastrointestinal disorders, active gastrointestinal bleeding or history of gastrointestinal bleeding 13. Patients with a history of asthma, urticaria, acute rhinitis, angioneurotic edema or any other allergic reaction after administ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the analgesic efficacy of Montelukast through the Visual Analog Scale (VAS) after 24 weeks, compared to placebo, in patients with hand erosive arthritis.;Secondary Objective: -Assess the efficacy of Montelukast measured as the increase of the hands’ functionality among the study groups during the treatment period. - Assess the changes observed by MRI on the radiological signs of the studied joints (synovitis, bone edema, bone erosions, and flexor tendon tenosynovitis) among the study groups during the treatment period. - Know the percentage of rescue medication use and withdrawals during the study. - Assess the quality-of-life differences among the study groups. - Assess the safety and tolerability of Montelukast.;Primary end point(s): Pain intensity difference in relation to baseline pain (PIDt) after 24 weeks, measured through the Visual Analog Scale (VAS);Timepoint(s) of evaluation of this end point: Baseline and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy assessment ?Assessment of the number of interphalangeal joints with pain on pressure at baseline visit and at weeks 4, 12 and 24. ?Assessment of the number of interphalangeal joints with clinical signs of inflammation at the baseline visit and at weeks 4, 12 and 24. ?Pain intensity (PI) at baseline visit and at weeks 4, 12 and 24. ?Pain intensity difference in relation to baseline pain (PIDt) at weeks 4 and 12. ?VAS scale(0-100mm) of the patient’s stiffness at the baseline visit and at weeks 4, 12 and 24. ?VAS scale(0-100mm) of overall disease activity, by evaluating physician and by patient at baseline visit and at weeks 4, 12 and 24. ?Assessment of the inflammatory activity through MRI at the baseline visit and at week 24. ?AUSCAN hand function scale at baseline visit and at weeks 4, 12 and 24. ?Grasping force using a pressure cuff (previously inflated to 60 mmHg) at the baseline visit and at weeks 4, 12 and 24. ?EuroQol-5d quality-of-life questionnaire at baseline visit and at week 24. ?Amount of patients using rescue medication. ?Biomarker measurement, comparison before and after the 24 weeks of treatment. Safety assessment ? Vital signs (body temperature, heart rate, respiratory rate and blood pressure) and general physical examination ? Abnormal tests ? Assessment of adverse events;Timepoint(s) of evaluation of this end point: Efficacy assessment ? Baseline, 4, 12 and 24 weeks ? Baseline, 4, 12 and 24 weeks ? Baseline, 4, 12 and 24 weeks ? Baseline, 4 and 12 weeks ? Baseline, 4, 12 and 24 weeks ? Baseline , 4, 12 and 24 weeks ? Baseline and 24 weeks ? Baseline, 4, 12 and 24 weeks ? Baseline, 4, 12 and 24 weeks ? Baseline and 24 weeks ? 4, 12 and 24 weeks ? Before and after 24 weeks of treatment Safety assessment ? Basaline, 4, 12, 24 weeks and follow up ? 12 weeks and follow up ? Basaline, 4, 12, 24 weeks and follow up | — |
Countries
Spain
Contacts
Public ContactSTART UP UNIT
SERMES PLANIFICACION S.L
Outcome results
None listed