Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritis

Phase 1

• Conditions: Rheumatoid Arthritis; MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2010-020992-21-SK
• Lead Sponsor: AB Science

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-06
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. Patient with rheumatoid arthritis diagnosed according to ACR criteria for at least 6 months.
2. Patient with ACR functional class I-III
3. Patient who have active RA consisting of
- = 6 swollen joints (over 66 swollen joints);- = 6 tender joints (over 68 tender joints);- and at least 2 out of 3 of the following:ESR/first hour = 20 mm; CRP = 10 mg/L;morning stiffness = 45 minutes at both screening and baseline.
4. Patient who failed (defined as active RA with stable dose during 3 months) methotrexate at a dose = 15 mg/week or any DMARD including biologics drugs if patients previously failed methotrexate at a dose = 15 mg/week or methotrexate at a dose = 15 mg/week in combination with any DMARD including biologics drugs (Biologic drugs being defined as any of the following therapies: anti-TNFa,Anti-CD20,Anti-IL1,Anti-IL6,CTLA4)
5. Patient with a disease onset at > 16 years of age
6. Patient with an adequate organ function:ACN = 2 x 109/L;White blood cells count = 4 x 109/L;Haemoglobin = 10 g/dL;PLT = 100 x 109/L;AST/ALT = 3 x ULN;Bilirubin = 1.5 x ULN;Creatinine clearance >60 mL/min;Albuminemia > 1 x LLN;Proteinuria < 30 mg/dL (1+) on the dipstick; in case of proteinuria = 1+ on the dipstick, 24 hours proteinuria < 1.5g/24 hours
7. Male or female patient aged 18 to 75 years,weight>50 kg,BMI between 18 and 35 kg/m²
8. No active infection (tuberculosis,HIV,hepatitis, ...)
9. Female patient of childbearing potential (entering the study after a menstrual period and who have a negative pregnancy test),who agrees to use two highly effective methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake.Acceptable forms of contraception include:A documented placement of an intrauterine device (IUD) or intrauterine system (IUS) and the use of a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps] used with spermicidal foam/gel/film/cream/suppository);Documented tubal ligation (female sterilization). In addition, a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps] used with spermicidal foam/gel/film/cream/suppository) should also be used;Double barrier method:Condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository;Any other contraceptive method with a documented failure rate of <1% per year;Abstinence
10. Male patients must use medically acceptable methods of contraception if your female partner is pregnant from the time of the first administration of the study drug until three months following administration of the last dose of study drug.Acceptable methods include:Condom;If you have undergone surgical sterilization (vasectomy with documentation of azoospermia) a condom should also be used. Male patients must use two highly effective methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake. The acceptable methods of contraception are as follows: Condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; Surgical sterilization (vasectomy with documentation of azoospermia) and a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps] used with spermicidal foam/gel/film/cream/suppository);Your female partner uses oral contraceptives (combination oestrogen/pro

Exclusion Criteria

1. Patient from whom the use of methotrexate is contraindicated as per its SPC (i.e. patient with severe renal or liver failure, patient with pre-existing blood dyscrasia, patient with alcohol abuse, patient with acute or chronic infection, patient with methotrexate intolerance, patient being treated with live attenuated vaccine)
2. Patient with documented fibromyalgia
3. Patient who have had a major surgery within 2 weeks prior to study entry
4. Patient with lactose intolerance
5. Patient presenting with cardiac disorders defined by at least one of the following conditions:
? Patient with recent cardiac history (within 6 months) of:
- Acute coronary syndrome
- Acute heart failure (class III or IV of the NYHA classification)
- Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death)
? Patient with cardiac failure class III or IV of the NYHA classification
? Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block)
? Syncope without known aetiology within 3 months
? Uncontrolled severe hypertension, according to judgment of the investigator, or symptomatic hypertension
6. Patient with history of primary malignancy < 5 years; except treated basal cell skin cancer or cervical carcinoma in situ
7. Patient with a severe and/or uncontrolled medical condition
8. Pregnant or lactating woman
9. Patient with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent.
10. Patient who were treated with methotrexate >20 mg cannot be included in the study
Previous treatments:
11. Administration of a DMARD (except methotrexate) within 4 weeks (or 5 half-lives, whichever is longer) prior to baseline except for leflunomide which requires a specific wash-out period of 12 weeks before baseline and infliximab which requires a wash-out period of 8 weeks.
12. Administration of more than one Non Steroidal Anti-Inflammatory Drug (NSAID) or change of dose of NSAID within 4 weeks of screening or NSAID use greater than the maximum recommended dose.
13. Administration of more than 10 mg/day of prednisone or equivalent or change in the dose of prednisone or equivalent, or having intra-articular corticosteroid injection or bolus intramuscular or intravenous treatment with corticosteroids (>20 mg prednisone or equivalent) within 4 weeks of screening.
14. Treatment with any investigational agent within 4 weeks of screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified