Phase
Condition
Rheumatoid Arthritis
Joint Injuries
Dermatomyositis (Connective Tissue Disease)
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult patients, >/= 18 years of age
Rheumatoid arthritis of >/= 1 year duration
Mild to moderate disease activity at screening (DAS 28 </= 4.5 and >2.6)
On methotrexate treatment for at least 12 weeks, at stable oral dose of (10)15 mg to 25 mg/week for at least 6 weeks prior to Day 1
Body weight </= 150 kg
Oral corticosteroids must have been at stable dose (maximum 10 mg/day) for at least 25out of 28 days prior to baseline
Exclusion
Exclusion Criteria:
Major surgery (including joint surgery) within 8 weeks prior to screening or plannedmajor surgery within 6 months after baseline
Rheumatic autoimmune disease other than rheumatoid arthritis
Functional class IV American College of Rheumatology (ACR) Classification
Prior history of or current inflammatory joint disease other than rheumatoid arthritis
Treatment with a biologic agent at any time prior to baseline
Treatment with traditional DMARDs other than methotrexate within 1 month (forleflunomide 3 months) prior to baseline
Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
Previous treatment with tocilizumab
Pregnant or lactating women
Uncontrolled disease states, such as asthma, psoriasis or inflammatory bowel diseasewhere flares are commonly treated with oral or parenteral corticosteroids
Known active current or history of recurrent bacterial, viral, fungal, mycobacterialor other infections
History of or currently active primary or secondary immunodeficiency
Evidence of active malignant disease, malignancies diagnosed within the previous 5years
Active tuberculosis requiring treatment within the previous 3 years
Positive for HIV infection
Study Design
Connect with a study center
Graz, 8036
AustriaSite Not Available
Graz-Eggenberg, 8020
AustriaSite Not Available
Hollabrunn, 2020
AustriaSite Not Available
Innsbruck, 6020
AustriaSite Not Available
Linz, 4020
AustriaSite Not Available
Salzburg, 5020
AustriaSite Not Available
Stockerau, 2000
AustriaSite Not Available
Wels, 4600
AustriaSite Not Available
Wien, 1160
AustriaSite Not Available
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