A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX
- Conditions
- -M069M069
- Registration Number
- PER-090-07
- Lead Sponsor
- GlaxoSmithKline,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 4
• Age 18 years
• Diagnosis of rheumatoid arthritis according to the American College of Rheumatology (classification ACR1987) of at least six months from the time of diagnosis to selection
• Active disease at the time of selection, defined by: 8 swollen joints (over 66 joints evaluated) and 8 painful joints (over 68 joints evaluated) and C reactive protein (CRP) 1.0 mg / dl or erythrocyte sedimentation rate ( VES) 22 mm / hour (with the Becton Dickinson Seditainer) and DAS28 3.2 (based on the VES) The joints will be reevaluated in the baseline assessment (Visit 2) to confirm compliance with the eligibility criteria. If possible, the joint re-evaluation should be carried out at the baseline visit (Visit 2), otherwise it may be carried out 3 days before Visit 2.
• Functional class of ARI, II or III (see definition of functional class of AR in Appendix 1)
• Inadequate response to previous or ongoing treatment with methotrexate,
• Subjects with a history of rheumatic autoimmune disease different from RA (except secondary Sjogren´s syndrome, significant systemic involvement secondary to RA (vasculitis, pulmonary fibrosis or Felty´s syndrome)
• Previous exposure to biological antirheumatic therapies that cause cell depletion including experimental compounds (eg, anti-CDlla, anti-CD19, anti-CD2L, anti-CD22, anti-BLyS / BAFF, anti-CD3, anti-CD4, anti- CD5, CAMPATH)
• Previous exposure to biological DMARDs
• Subjects who have received any of the following treatments in the 4 weeks prior to Visit 2: - Antineoplastic treatments (for example, alkylating agents, antimetabolites, purine analogues, monoclonal antibodies) - Glucocorticoids, unless they are administered in doses equivalent to Prednisolone 10 mg / day - Intrarticular corticosteroids, IM or IV - Vaccination with live / attenuated viruses - Hydroxychloroquine - Cyclosporine - Azathioprine - Penicillamine
• Exposure to sulfasalazine in the 6 weeks prior to Visit 2
• Exposure to leflunomide in the 12 weeks prior to Visit 2, except that the subject has completed oral treatment with cholestyramine for drug rest according to locally accepted clinical practices
• Exposure to treatment with gold salts 12 weeks before Visit 2
• Exposure to immunoglobulins IV 24 weeks before Visit 2
• Past or current malignant melanoma
• Current Neoplasiamalignapasadao except: - Stage IB or less cervical carcinoma - Non-invasive basal cell carcinoma or squamous cell carcinoma - Other cancers with complete remission duration> 5 years
• Chronic or active infectious disease in progress requiring systemic treatment, such as the following, but not limited to: chronic kidney infection, chronic chest infection with bronchiectasis, tuberculosis and active hepatitis B and C
• Clinically significant heart disease, including instable angina, acute myocardial infarction in the six months prior to selection, congestive heart failure, known QT segment abnormalities, and arrhythmias requiring treatment, with the exception of extrasystoles or minor conduction abnormalities.
• Significant, concurrent, uncontrolled clinical conditions, including, but not limited to: renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, psychiatric brain diseases or evidence of diseases
• History of significant cerebrovascular disease
• Known positivity for HIV
• Laboratory values of the selection (according to the central laboratory): - Hemoglobin <5.6 mmoI / 1 (9.0 g / dl) - Neutrophils <2 x lOV 1 - Platelets <100 x loV 1- Serum IgG 3.0 times the upper limit of normal - S-AST> 1.5 times the upper limit of normal - S-ALP> 2 times the upper limit of normal - S-creatinine> 133 pmol / I (1.5 mg / dl)
• Positive serology for hepatitis B (HB) defined as: - Positive test for HBsAg and / or - Positive test for anti-HBc and anti-HBs Subjects with documented vaccination against Hepatitis B (primary and secondary immunization plus reinforcement) will be considered negative
• Positive PCR in plasma / leukocytes for JC Virus (JCV) virus (any compartment)
• Known hypersensitivity to medicinal product components in research
• Subjects who have received treatment with any other non-commercialized drug substance or experimental treatment in the 4 weeks prior to selection
• Current participation in any other clinical study with a
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method