A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate Versus RoActemra/Actemra Monotherapy in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate
Launched by HOFFMANN-LA ROCHE · Jul 20, 2011
Trial Information
Current as of June 20, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Adult patients, \>/= 18 years of age
- • Active moderate to severe rheumatoid arthritis (DAS28 \>/= 3.2) at baseline
- • Currently receiving methotrexate for at least 12 weeks, at a stable oral dose of at least 15 mg/week for at least 6 weeks prior to treatment (Day 1)
- • Body weight \< 150 kg
- • Oral corticoids must have been at stable dose for at least 25 out of 28 days prior to baseline; maximum dose 10 mg/day
- Exclusion Criteria:
- • Pregnant or nursing women
- • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after baseline
- • Rheumatic autoimmune disease other than RA
- • Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis
- • Prior history of or current inflammatory joint disease other than RA
- • Treatment with a biologic agent at any time prior to baseline
- • Treatment with traditional DMARDs other than methotrexate within 1 month (for leflunomide 3 months) prior to baseline
- • Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
- • Previous treatment with RoActemra/Actemra
- • History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
- • Known active current or history of recurrent infection
- • History of or currently active primary or secondary immunodeficiency
- • Active tuberculosis requiring treatment within the previous 3 years
- • Positive for HIV infection
About Hoffmann La Roche
Hoffmann-La Roche, commonly known as Roche, is a global leader in biotechnology and pharmaceuticals, committed to advancing healthcare through innovative research and development. With a strong focus on oncology, immunology, infectious diseases, and central nervous system disorders, Roche leverages cutting-edge science to deliver transformative therapies and diagnostics. The company is dedicated to improving patient outcomes by conducting rigorous clinical trials and collaborating with healthcare professionals and organizations worldwide. Roche's unwavering commitment to precision medicine and personalized healthcare positions it at the forefront of the industry, driving progress in the quest for effective treatments and improved patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cordoba, , Spain
Valencia, , Spain
Madrid, , Spain
Granada, , Spain
Sevilla, , Spain
Salamanca, , Spain
Guadalajara, , Spain
Lugo, , Spain
Barakaldo, Vizcaya, Spain
Tenerife, , Spain
Barcelona, , Spain
Leon, , Spain
Toledo, , Spain
Terrassa, Barcelona, Spain
Fuenlabrada, Madrid, Spain
Cádiz, Cadiz, Spain
Santiago De Compostela, La Coruña, Spain
Bilbao, Vizcaya, Spain
Vigo, Pontevedra, Spain
Caceres, , Spain
Badalona, Barcelona, Spain
Galdakao, Vizcaya, Spain
Badajoz, , Spain
Alcala De Henares, Madrid, Spain
Torrevieja, Alicante, Spain
Albacete, , Spain
Las Palmas De Gran Canaria, Las Palmas, Spain
Villajoyosa, Alicante, Spain
Torrelavega, Cantabria, Spain
Menorca, Islas Baleares, Spain
Valenica, Valencia, Spain
Cartagena, Murcia, Spain
El Palmar, Murcia, Spain
A Coruna, La Coruña, Spain
Malaga, , Spain
Orihuela, Alicante, Spain
Merida, Badajoz, Spain
Granollers, Barcelona, Spain
Villarreal, Castellon, Spain
Valdemoro, Madrid, Spain
Manises, Valencia, Spain
Patients applied
Trial Officials
Clinical Trials
Study Director
Hoffmann-La Roche
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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