Activity and safety of oral administration of SSR150106XB for the reduction of inflammation in patients with active rheumatoid arthritis (RA): A 4-week, multi-center, randomized, double-blind, placebo-controlled parallel group study of 90 µg administrered once daily and 90µg once every other day - ACCORD-RA

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 75

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

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 < 30 cc/min
AST > 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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