Patients with active rheumatoid arthritis MedDRA version: 9.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis
Conditions
Interventions
Product Name: SSR150106XB
Product Code: SSR150106XB
Pharmaceutical Form: Oral solution
INN or Proposed INN: NA
CAS Number: 335267-09-9
Current Sponsor code: SSR150106XB
Other descriptive name: NA
Conc
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis of RA for at least 6 months (ARA 1987) who are either treatment-naïve or who had previously discontinued their RA-directed medication due to either intolerability or insufficient efficacy. Active disease at screening and baseline as defined by: At least 9 out of the 68 joints assessed as painful or tender on motion At least 6 out of the 66 joints assessed as swollen Morning stiffness of at least 45 min C-reactive protein (CRP) =1.8 mg/dL Non-PMs CYP2D6 Metabolizer status, confirmed by genotyping, prior to randomization 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Functional RA class IV (ACR 1991) RA treatment failure with 3 or more established DMARDs, immunosuppressant and newer biologic agents Previous treatment within the following time periods before first intake of investigational product (IP): Methotrexate - 6 weeks Hydroxychloroquine, sulfasalazine, gold salts, penicillamine, azathiaprine, cyclosporine mycophenylate mofetil - 4 weeks Leflunomide – 6 weeks Receptor antagonists: etanercept, anakinra, abatacept – 4 weeks Monoclonal antibodies – 12 weeks Prior treatment with rituximab Intra-articular corticosteroid injections less than 4 weeks before first intake of IP Oral glucocorticoids greater than 10 mg prednisone (or equivalent) daily Analgesics and NSAID/COX-2 inhibitor with daily dose(s) greater than approved for treatment of RA Patients with conditions/concomitant diseases making them non-evaluable for the primary efficacy endpoint: Pain condition with etiology other than from RA History of an acute inflammatory joint disease other than RA Refusal or inability to give informed consent Patients likely to be non-compliant or unlikely to complete the study Fever (oral temperature > 38oC), chronic infections or inter-current infections requiring antimicrobial therapy: previous or active infection with hepatitis B or C or other liver disease Known or suspected HIV/AIDs Past or current treatment for tuberculosis History of multiple allergic reactions to drugs Presence or history of cancer Congenital or acquired immunodeficiency Drug or alcohol abuse within 2 years of study entry Have a history of significant other concomitant illness that could interfere with the patient’s participation in the study Abnormal laboratory tests: Creatinine clearance 2 X ULN ALT > 2 X ULN Alkaline phosphatase > 2 X ULN Conjugated bilirubin > 2 X ULN Complete blood count: Hemoglobin < 8.5 g/dl WBC < 3.5 x 109 Neutrophils < 1.5 x 109 Platelets < 100 x 109 Any investigational drug within a 60-day period or 5 half-lives Organic neurologic disorder or somatic symptomatology Organic gastrointestinal disorder or somatic symptomatology Pregnant or breast-feeding women, Women of childbearing potential not protected by effective contraceptive measures Concomitant treatment with moderate or potent CYP2D6 inhibitors Concomitant treatment with potent CYP3A4 inhibitors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of SSR150106XB 90 µg once daily and SSR150106XB 90 µg once every other day to reduce systemic inflammation in patients with active rheumatoid arthritis, as measured by changes in the acute phase protein, C-reactive protein, over a 4-week treatment period;Secondary Objective: To assess the effect of SSR150106XB 90 µg once daily and SSR150106XB 90 µg once every other day to reduce systemic inflammation in patients with active rheumatoid arthritis, as measured by changes in acute phase protein, serum amyloid A (SAA) and cytokine interleukin-6 (IL-6), and clinical ACR20/ACR50/ACR70 % improvement responder rates (composite index) and for each of the individual index components, Disease Activity Score (DAS28-(CRP)), duration (hours/minutes) of morning stiffness over a 4-week treatment period To assess the effect of SSR150106XB to reduce pain intensity in the early dosing period (Days 1-14), as assessed by changes from baseline in pain intensity on Visual Activity Scale (VAS). To obtain evidence of the safety and tolerability of SSR150106XB in the treatment of patients with active rheumatoid arthritis. To document plasma concentrations of SSR150106 and of the active metabolite SSR150655;Primary end point(s): Change in mean C-reactive protein (CRP) level at endpoint (Visit 7) as compared to baseline | — |
Countries
Czech Republic
Outcome results
None listed