Stratification of biologic therapies for rheumatoid arthritis by pathobiology

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2015
INTERVENTION: Participants are randomly allocated to one of three groups: Group 1: Participants receive 50mg etanercept administered subcutaneously once weekly for the study duration. Group 2: Participants receive 1000mg rituximab by iv infusion on days 1 and 15. This cycle is repeated every 24 weeks. Group 3: Participants receive 162 mg tocilizumab administered subcutaneously once weekly for the study duration. CONDITION: Topic: Musculoskeletal disorders; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal ; Musculoskeletal Diseases ; Rheumatoid Arthritis PRIMARY OUTCOME: Treatment efficacy is determined by calculating the number of patients with an ACR 20 response at 16 weeks. SECONDARY OUTCOME: Not provided at time of registration INCLUSION CRITERIA: Current inclusion criteria as of 08/09/2017: 1. 2010 ACR / EULAR Rheumatoid Arthritis classification criteria for a diagnosis of RA * 2. Patient with DMARD failure eligible for anti‐TNF‐a therapy as per UK NICE guidelines** 3. Patients must have a minimum of 3 swollen joints – the joint selected for biopsy and a minimum of 2 from 28 joint count set, as assessed at biopsy visit 4. Selected joint for biopsy must be minimum grade 2 synovial thickening, as assessed at the biopsy visit 5. 18 years of age and over 6. Patients must be capable of giving informed consent and the consent must be obtained prior to any screening procedures * The ACR/EULAR classification for a diagnosis of RA could have been at any time in the patient’s disease history; the score does not need to be 6 or more at screening. ** Current NICE guidelines available at the following link: http://www.nice.org.uk/guidance/ta375. Previous INCLUSION CRITERIA: 1. 2010 ACR
Epistemonikos ID: 440c623faa87cc3eea03532781c1ddec95c7dc00
First added on: Aug 23, 2024