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

• Conditions: Rheumatoid Arthritis; MedDRA version: 17.1Level: 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-DE
• Lead Sponsor: AB Science

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-08
• Last Update Posted: 28 September 2015

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/progesteron

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 preexisting
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.

Study & Design

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