Rheumatoid Arthritis MedDRA version: 17.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
AB Science
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Cumulative response on ACR50 (ie. response from week 8 to week 24);Secondary Objective: • Response assessment: - Cumulative response on ACR20 (ie. response from W8 to W24), - Cumulative response on ACR70 (ie. response from W8 to W24), - Cumulative response on ACR90 (ie. response from W8 to W24) - ACRn from W8 to W24 - Time to first response according to ACR20 and ACR50 - DAS28 from week 8 to week 24: • DAS28 (disease activity score) • DAS28 50%, between 25 and 50%, between 0 and 25% or no improvement • Quality of life assessment: - Visual assessment scale from week 8 to week 24: pain, asthenia, general health - Quality of life assessed of SF36 from W8 to W24 - Health assessment questionnaire (HAQ) score and from W8 to W24 - Hamilton score from W8 to W24 - Fatigue Impact scale from W8 to W24 • Safety assessments: Adverse events, vital signs, laboratory data. ;Primary end point(s): Cumulative response on ACR50 (ie. response from week 8 to week 24) ;Timepoint(s) of evaluation of this end point: Cumulative response on ACR20 (ie. response from week 8 to week 24) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Response assessment: - Cumulative response on ACR20 (ie. response from week 8 to week 24), - Cumulative response on ACR70 (ie. response from week 8 to week 24), - Cumulative response on ACR90 (ie. response from week 8 to week 24) - ACRn from week 8 to week 24 - Time to first response according to ACR20 and ACR50 - DAS28 from week 8 to week 24: • DAS28 (disease activity score) • DAS28 50%, between 25 and 50%, between 0 and 25% or no improvement • Quality of life assessment: - Visual assessment scale from week 8 to week 24: -pain -asthenia -general health - Quality of life assessed of SF36 from week 8 to week 24 - Health Assessment Questionnaire (HAQ) score and from week 8 to week 24 - Hamilton score from week 8 to week 24 - Fatigue Impact scale from week 8 to week 24 • Safety assessments: Adverse events, vital signs, laboratory data. ;Timepoint(s) of evaluation of this end point: response from week 8 to week 24 | — |
Countries
Argentina, Bosnia and Herzegovina, Czech Republic, Germany, Greece, India, Mexico, Monaco, Morocco, Philippines, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Taiwan, Thailand, Tunisia, Ukraine, United States
Contacts
Public ContactIva Nesic
AB Science
Outcome results
None listed