Rheumatoid Arthritis MedDRA version: 15.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: RoActemra
Pharmaceutical Form: Concentrate for solution for infusion
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intra
Sponsors
Roche Nederland B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant, non-nursing female 2. = 18 years of age 3. Early RA (disease symptoms =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Rheumatic autoimmune disease other than RA, including systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis. Patients with interstitial pulmonary fibrosis and still able to tolerate MTX therapy are permitted. Sjögren’s Syndrome with RA is permitted 2.Current inflammatory joint disease other than RA (e.g. gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) 3. Glucocorticoids used for RA 142 µmol/L in female patients and > 168 µmol/L in male patients or an active renal disease 11.ALT or AST > 1.5 x ULN (if initial sample yields ALT or AST > 1.5 x ULN, a second sample may be taken and tested during the screening period) 12.Platelet count 10 mmol/L (> 900 mg/dL) at screening (fasted) 19.Pregnant women or nursing (breastfeeding) mothers 20.Females of child-bearing potential who are not using reliable means of contraception (such as physical barrier [patient and partner], contraceptive pill or patch, spermicide and barrier, or intrauterine device) 21.History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies 22.Chest X-ray (CXR) at screening showing evidence of any clinically significant abnormality 23.Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus) or GI disease 24.In patients with a history of complicated diverticulitis, the treating physician needs to consider the benefit-risk ratio 25.A known history of chronic ulcerative lower GI disease such as Crohn’s disease, ulcerative colitis, or other symptomatic lower GI conditions that might predispose to perforations 26. Active TB requiring treatment within the previous 3 years. Patients with a positive purified protein derivative tuberculin skin test (PPD) at screening as per local guidelines are not eligible for the study unless they complete treatment for latent TB and have a negative CXR at enrollment. Patients treated for tuberculosis with no recurrence in 3 years are permitted 27.Known uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel disease, where flares are commonly treated with oral or parenteral glucocorticoids 28.Current liver disease as determined by investigator. Patients with prior history of ALT elevation are not excluded 29. Known active current or history of recurrent bacterial, viral,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Primary endpoint of the present study is the sustained remission rate (SRR), i.e. the proportion of patients with early RA who achieve sustained remission. In individual patients, sustained remission is considered to be achieved if an uninterrupted period of approximately 6 months (at least 23 weeks) can be identified, over which: •At least 6 DAS28 values are available, including one at the beginning and one at the end of the period •All values are <2.6, with the exception of up to 2 values which can be between 2.6 and 3.2 provided that the investigator considers the patient to be in clinical remission for RA and documents the reason for the RA-unrelated elevation of DAS28 (such as an infection) ;Main Objective: To compare the number of patients with early RA who achieve sustained remission with three different regimens: tocilizumab combined with tightly controlled MTX, tightly controlled MTX as monotherapy and tocilizumab as monotherapy. The main focus is the contrast between the combination therapy and the MTX monotherapy followed by the contrast between the two monotherapy treatments.;Secondary Objective: To compare the progression of radiographic characteristics of joint damage among the three treatment strategies by use of the change in SharpvanderHeijde score. To compare clinical efficacy between the three treatment strategies by use of the ACR and EULAR response criteria. To study safety in the context of the three treatment strategies, including the: - occurrence of serious adverse events leading to withdrawal. - occurrence of serious infections - number of patients who are unable to use adequate dosage of MTX due to increase of liver enzymes To study differences in changes in functional disability, fatigue, quality of life and cost effectiveness in the three treatment strategy groups by use of the: Dutch consensus HAQ, the FACIT-fatigue, the IPQR, the SF-36, VAS pain and general wellbeing Questionnaires, a Dutch Healthcare reso | — |
Countries
Netherlands
Outcome results
None listed