Phase
Condition
Rheumatoid Arthritis
Dermatomyositis (Connective Tissue Disease)
Musculoskeletal Diseases
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: During study entry
Able and willing to give written informed consent and comply with the requirements ofthe study protocol;
Participants with Rheumatoid Arthritis (RA) for at least 6 months, diagnosed accordingto the revised 1987 American College of Rheumatology (ACR) criteria for theclassification of RA;
Receiving treatment on an outpatient basis;
Experienced an inadequate response to previous or current treatment with DMARDsbecause of toxicity or inadequate efficacy;
Disease activity score (DAS28) greater than or equal to (>=) 3.2 at screening andbaseline visit.
Age >= 18 years;
Participants of reproductive potential (males and females) using a reliable means ofcontraception (for example [e.g.] contraceptive pill, intrauterine device, physicalbarrier);
Female participants with childbearing potential - a negative urine pregnancy testwithin two weeks prior to first rituximab treatment. During Re-Treatment
Achieved moderate or good response according to the EULAR response criteria during anyvisit including visits in the post-treatment period;
DAS28 >=3.2;
The participants has not been withdrawn into the safety follow-up at any time pre orpost Week 24;
36 weeks or more have passed since the participant's first rituximab infusion;
No evidence of any new medical condition or laboratory test results;
In participants who were known to be positive to hepatitis B core antibody (HBcAb) -documented negative hepatitis B viral DNA (HBV-DNA) test and aspartateaminotransferase (AST)/alanine aminotransferase (ALT) less than or equal to (<=) 2.5xupper limit of normal (ULN) within the last 12 weeks;
Female participants with childbearing potential - a negative urine pregnancy testimmediately prior to treatment initiation.
Exclusion
Exclusion Criteria:
Rheumatic autoimmune disease other than RA, or significant systemic involvementsecondary to RA (e.g., vasculitis, pulmonary fibrosis or Felty's syndrome). Sjogren'ssyndrome with RA was permitted;
Functional class IV as defined by the ACR Classification of Functional Status in RA;
History of, or current, inflammatory joint disease other than RA (e.g., gout, reactivearthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) orother systemic rheumatic disorder disorder (e.g., inflammatory bowel disease,scleroderma, inflammatory myopathy); Excluded Previous/Concomitant Medications
Previous or concurrent treatment with any anti TNF-alpha therapy;
Treatment with any investigational agent within 4 weeks of screening;
Previous treatment with any cell depleting therapies excluding rituximab, includinginvestigational agents;
Immunization with a live vaccine within 4 weeks prior to the baseline visit. Exclusions for General Safety
History of severe allergic or anaphylactic reactions to humanized or murine monoclonalantibodies;
Significant cardiac or pulmonary disease (including obstructive pulmonary disease).
Evidence of significant uncontrolled concomitant diseases such as cardiovasculardisease, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinaldisorders.
Known active bacterial, viral, fungal, mycobacterial or other infection (includingtuberculosis, or atypical mycobacterial disease, but excluding fungal infections ofnail beds), or any major episode of infection requiring hospitalization or treatmentwith IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeksprior to screening;
History of recurrent significant infection or history of recurrent bacterialinfections;
Primary or secondary immunodeficiency (history of, or currently active);
Active cancer, including solid tumors and hematologic malignancies (except basal cellor squamous cell carcinoma of the skin that have been excised and cured);
Pregnant women or nursing (breast feeding) mothers;
Participants with lack of peripheral venous access; Laboratory Exclusion Criteria (at Screening)
Positive tests for hepatitis B surface antigen (HBsAg) and/or positive tests for HBcAbassociated with detectable HBV-DNA or hepatitis C antibody (HCAb) and hepatitis Cviral RNA (HCV-RNA).
Study Design
Connect with a study center
Barzilai; Rheumatology
Ashkelon, 78306
IsraelSite Not Available
Soroka Medical Center; Reumatology
Beer Sheva, 8410101
IsraelSite Not Available
Assaf Harofe; Dept of Medicine B
Beer Yaakov, 6093000
IsraelSite Not Available
Hillel Yaffe MC; Internal C - Rheumatology
Hadera, 38100
IsraelSite Not Available
Bnei Zion Medical Center; Rheumatology
Haifa, 3339419
IsraelSite Not Available
Carmel Hospital; Rheumatology Dept
Haifa, 34362
IsraelSite Not Available
Rambam Medical Center; Rheumatology
Haifa, 3109601
IsraelSite Not Available
Wolfson Hospital; Rheumatology
Holon, 58100
IsraelSite Not Available
Hadassah Mount Scopus Hospital; Rheumatology
Jerusalem, 91240
IsraelSite Not Available
Meir Medical Center; Internal Dept A
Kfar Saba, 44281
IsraelSite Not Available
Shaare Zedek Medical Center; Rheumatology Dept
Naharia, 22100
IsraelSite Not Available
Nahariya Hospital; Rheumatology Dept
Nahariya, 22100
IsraelSite Not Available
EMMS Nazareth; Internal Department A
Nazareth, 16100
IsraelSite Not Available
Beilinson Medical Center; Rheumatology
Petach Tikva, 4941492
IsraelSite Not Available
Kaplan Medical Center; Reumatology
Rehovot, 76100
IsraelSite Not Available
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Rishon Lezion, 70300
IsraelSite Not Available
Sourasky / Ichilov Hospital; Rheumatology
Tel Aviv, 6423906
IsraelSite Not Available
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