drugset / Trial / NCT01034137
A Study of Tocilizumab and Methotrexate in Combination or as Monotherapy in Treatment-Naïve Patients With Early Rheumatoid Arthritis
RandomizedParallel-groupDouble-blindTreatment
Summary
This randomized, double-blind, placebo-controlled study will compare the efficacy with regard to sustained remission and safety of tocilizumab and methotrexate, in combination or as monotherapy, in treatment-naïve patients with early rheumatoid arthritis. Patients will be randomized to receive either tocilizumab (8mg/kg iv every 4 weeks) plus weekly methotrexate (po in ascending doses), or tocilizumab (8mg/kg iv every 4 weeks) plus placebo, or methotrexate plus placebo. Anticipated time on study treatment is 2 years, and target sample size is 300.
Timeline
- Start
- 2010-01
- Primary completion
- 2014-09
- Completion
- 2014-09
Outcome
Met primary endpoint
registry Tocilizumab + Methotrexate vs Methotrexate + Placebo Tocilizumab; p < 0.001; Risk Ratio (RR) 1.996 NCT01034137 ↗
registry Tocilizumab + Placebo Methotrexate vs Methotrexate + Placebo Tocilizumab; p < 0.001 NCT01034137 ↗
Publications
- Gosselt HR, Verhoeven MMA, de Rotte MCFJ, Pluijm SMF, Muller IB, Jansen G, Tekstra J, Bulatovic-Calasan M, Heil SG, Lafeber FPJG, Hazes JMW, de Jonge R. Validation of a Prognostic Multivariable Prediction Model for Insufficient Clinical Response to Methotrexate in Early Rheumatoid Arthritis and Its Clinical Application in Evidencio. Rheumatol Ther. 2020 Dec;7(4):837-850. doi: 10.1007/s40744-020-00230-7. Epub 2020 Sep 14.
- Teitsma XM, Yang W, Jacobs JWG, Petho-Schramm A, Borm MEA, Harms AC, Hankemeier T, van Laar JM, Bijlsma JWJ, Lafeber FPJG. Baseline metabolic profiles of early rheumatoid arthritis patients achieving sustained drug-free remission after initiating treat-to-target tocilizumab, methotrexate, or the combination: insights from systems biology. Arthritis Res Ther. 2018 Oct 15;20(1):230. doi: 10.1186/s13075-018-1729-2.
- Teitsma XM, Jacobs JWG, Welsing PMJ, de Jong PHP, Hazes JMW, Weel AEAM, Petho-Schramm A, Borm MEA, van Laar JM, Lafeber FPJG, Bijlsma JWJ. Inadequate response to treat-to-target methotrexate therapy in patients with new-onset rheumatoid arthritis: development and validation of clinical predictors. Ann Rheum Dis. 2018 Sep;77(9):1261-1267. doi: 10.1136/annrheumdis-2018-213035. Epub 2018 May 14.
- Teitsma XM, Jacobs JWG, Welsing PMJ, Petho-Schramm A, Borm MEA, van Laar JM, Lafeber FPJG, Bijlsma JWJ. Radiographic joint damage in early rheumatoid arthritis patients: comparing tocilizumab- and methotrexate-based treat-to-target strategies. Rheumatology (Oxford). 2018 Feb 1;57(2):309-317. doi: 10.1093/rheumatology/kex386.
- Teitsma XM, Jacobs JWG, Welsing PMJ, Petho-Schramm A, Borm MEA, Hendriks L, Denissen NHAM, van Laar JM, Lafeber FPJG, Bijlsma JWJ. Patient-reported outcomes in newly diagnosed early rheumatoid arthritis patients treated to target with a tocilizumab- or methotrexate-based strategy. Rheumatology (Oxford). 2017 Dec 1;56(12):2179-2189. doi: 10.1093/rheumatology/kex319.
- Teitsma XM, Jacobs JWG, Mokry M, Borm MEA, Petho-Schramm A, van Laar JM, Bijlsma JWJ, Lafeber FPJ. Identification of differential co-expressed gene networks in early rheumatoid arthritis achieving sustained drug-free remission after treatment with a tocilizumab-based or methotrexate-based strategy. Arthritis Res Ther. 2017 Jul 20;19(1):170. doi: 10.1186/s13075-017-1378-x.
- Bijlsma JWJ, Welsing PMJ, Woodworth TG, Middelink LM, Petho-Schramm A, Bernasconi C, Borm MEA, Wortel CH, Ter Borg EJ, Jahangier ZN, van der Laan WH, Bruyn GAW, Baudoin P, Wijngaarden S, Vos PAJM, Bos R, Starmans MJF, Griep EN, Griep-Wentink JRM, Allaart CF, Heurkens AHM, Teitsma XM, Tekstra J, Marijnissen ACA, Lafeber FPJ, Jacobs JWG. Early rheumatoid arthritis treated with tocilizumab, methotrexate, or their combination (U-Act-Early): a multicentre, randomised, double-blind, double-dummy, strategy trial. Lancet. 2016 Jul 23;388(10042):343-355. doi: 10.1016/S0140-6736(16)30363-4. Epub 2016 Jun 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methotrexate | Small molecule | 30 mg | Oral |
| Subject | Tocilizumab | Monoclonal antibody | 8 mg/kg | Intravenous |