PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP-690,550 COMPARED TO METHOTREXATE IN METHOTREXATE-NAIVE PATIENTS WITH RHEUMATOID ARTHRITIS
- Conditions
- -M069M069
- Registration Number
- PER-029-10
- Lead Sponsor
- PFIZER S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 15
• Active, moderate to severe rheumatoid arthritis with joint erosions or positive IgM rheumatoid factor (FR) or antibodies against cyclic citrullinated peptide (anti-CCP) as described in section 4.1.1.
• Compliance with all eligibility criteria
• The patient must meet the American College of Rheumatology (ACR) classification criteria for the diagnosis of rheumatoid arthritis (RA), meeting at least four of the seven criteria described in Appendix 1.
• Signs of at least three different joint erosions on the posteroanterior (PA) radiographs of the hands and wrists or anteroposterior (AP) of the feet (locally evaluated) OR, if there are no radiological indications of joint erosions, the patient should have IgM rheumatoid factor positive (FR-i-), as determined by an acceptable laboratory method, OR antibodies against the cyclic citrullinated peptide (anti-CCP +), as determined by an acceptable laboratory method.
• The patient must have active disease at the time of selection and the baseline
• The patient must belong to class I, II or III according to the revised criteria of the 1991 ACR of the global functional status in RA
• Minimum age of 18 years.
• The patient has discontinued all prohibited concomitant medications for the time required before the first dose of the study drug and is only taking those concomitant medications in the doses and frequency allowed by the protocol.
• Women of childbearing age should have a negative pregnancy test before being included in this study.
• Sexually active women of childbearing age and men whose partners are women of childbearing age will be required to use appropriate contraceptive methods during their participation in this trial; It is also mandatory in women and men treated with methotrexate.
• Absence of signs of active, latent or poorly treated Mycobacterium tuberculosis (TB) infection
• Patients who have received more than 3 weekly doses of MTX or less than 3 weekly doses after discontinuation due to an adverse event attributed to methotrexate.
• Pregnancy or active breastfeeding.
• Blood dyscrasias, including confirmed values of: Hemoglobin <9 g / dl or hematocrit <30%, WBC count <3.0 x 10 ^ 9 / L, Absolute neutrophil count <1.2 x 10 ^ 9 / L , Platelet count <100 x 10 ^ 9 / L.
• Estimated GFR <60 ml / min calculated with the formula developed by the study group for the modification of the diet in nephropathies (MDRD), the equation of diet modification in abbreviated nephropathies (aMDRD)
• AST or ALT greater than 1.5 times the upper limit of normal at the time of selection or any analytical abnormality with uncontrolled clinical importance that could affect the interpretation of the study data or the patient´s participation in the study.
• Renal, hepatic, hematologic, digestive, metabolic (including clinically significant hypercholesterolemia), severe, progressive or uncontrolled neurological disease, including pleural effusions or ascites: and situations that contraindicate treatment with MTX, such as the presence of severe or significant renal impairment or major hepatic impairment.
• severe, progressive or uncontrolled chronic epatopathy such as fibrosis, cirrhosis or recent or active hepatitis,
• History of any other rheumatic autoimmune disease, except Sjogren´s syndrome.
• History of infection of a joint prosthesis at some time, with the prosthesis still in place.
• History of lymphoproliferative disorders, such as lymphoproliferative disorder related to Epstein Barr virus (EBV), lymphoma, leukemia or signs and symptoms indicative of current lymphatic disease.
• History of recurrent herpes zoster (more than one episode) or disseminated (a single episode) or disseminated herpes simplex (a single episode).
• History of any infection in need of hospitalization or parenteral antibiotic treatment or considered of clinical importance by the investigator, in the six months prior to the administration of the first dose of the study drug.
• History of any infection that has required antibiotics in the two weeks prior to the first dose of the study drug.
• Any previous treatment with medications or therapies that reduce lymphocytes without selectivity for strain B [p. eg, alemtuzumab (Campath), alkylating agents (eg, cyclophosphamide or chlorambucil), total lymphatic irradiation, etc.]. Patients who have received rituximab or other drugs for selective removal of B lymphocytes (including experimental medications) will be eligible if they have not received such treatment for at least one year before the baseline period of the study and have normal CD counts. 19/20 + through FACS analysis.
• Any patient who has received live or attenuated microorganism vaccines in the six weeks prior to the first dose of the study drug or who will receive these vaccines at any time during the treatment or during the six weeks after the drug discontinuation. study. (See section 4.5.2 for more information regarding the need to avoid contact with people who may be vaccinated.)
• Patients with any disorder that may affect the oral absorption of medications, such as gastrectomy, clinically important diabetic gastroenteropathy or certain types of bariatric surgery, such as gastric bypass. Procedures such as the application of gastric bands, which simply divide the sto
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method