Adult Rheumatoid Arthritis MedDRA version: 14.1 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: Intr
Sponsors
Aarhus University Hospital, Department of Rheumatology U
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients (>/= 18 years) with rheumatoid arthritis according to the ACR/EULAR (2010) classification criteria (1) who have been diagnosed /= 2.6 • Number of swollen joints >/= 1 • Receiving treatment on an outpatient basis • Negative pregnancy test (serum HCG) for women of childbearing potential prior to trial start. Fertile women included in the trial should use contraception during the entire trial period (i.e. one of the following methods: Oral contraception, intrauterine device (IUD), depot injection of progesterone, subdermal implantation, contraceptive vaginal ring, transdermal depot plaster). In addition, contraception should be used for a period of 150 days after any discontinuation of trial medicine. • Ability and willingness to give written informed consent and to meet the requirements of the trial protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 180
Exclusion criteria
Exclusion criteria: 1. Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization 2. Rheumatic autoimmune disease other than rheumatoid arthritis 3. Functional class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis 4. Prior history of or current inflammatory joint disease other than RA 5. Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) of screening 6. Previous treatment with any TNF-a inhibitor, tocilizumab, rituximab and abatacept 7. Pregnant women or nursing (breastfeeding) mothers 8. History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies incl. tocilizumab. Hypersensitivity to the active substance or to latex or any other excipients 9. Previous treatment with any cell-depleting therapy 10. Primary or secondary immunodeficiency (history of or currently active) 11. Known active current or history of recurrent infection (including TB) 12. Body weight of > 150 kg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In a multicentre, randomized, two-armed, parallel group, double-blind design in patients with early rheumatoid arthritis to investigate whether it is possible by adding tocilizumab to achieve: 1. Inflammatory control as assessed by number of patients who achieve remission (DAS28 0.5 units) ;Secondary Objective: • Changes in DAS28 assessment • Proportion of patients with DAS28 remission • Changes in ACR-N assessment • Proportion of patients with ACR/EULAR BOOLEAN-based remission • Proportion of patients with ACR50/70/90 response • Changes in HAQ assessment • Proportion of patients with a HAQ score of 0,5 or less • Changes in Total Sharp Score (TSS) assessment • Changes in Joint Spacing Narrowing (JSN) assessment • Changes in Joint Erosions (JE) assessment • Changes in DXR as assessed by X-ray of the hands • Changes in DEXA of the lumbar spine and hip joints • Frequency and change in RAMRIS (MR score: synovitis, erosion, oedema, composite score) • Number of patients receiving intra-articular glucocorticosteroid injections between visit 1 – 3, 4 – 6, 7 – 16 • Cumulated dose of intra-articular glucocorticosteroid administered between visit 1 – 3, 4 – 6, 7 – 16 • Frequency and severity of adverse events including serious adverse events ;Primary end point(s): • Proportion of patients achieving a DAS28 remission ( 0.5 units). ;Timepoint(s) of evaluation of this end point: Evaluation will be after 12 months of treatment with tocilizumab, which is month 16 in the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Changes in DAS28 assessment • Proportion of patients with DAS28 remission • Changes in ACR-N assessment • Proportion of patients with ACR/EULAR BOOLEAN-based remission • Proportion of patients with ACR50/70/90 response • Changes in HAQ assessment • Proportion of patients with a HAQ score of 0,5 or less • Changes in Total Sharp Score (TSS) assessment • Changes in Joint Spacing Narrowing (JSN) assessment • Changes in Joint Erosions (JE) assessment • Changes in DXR as assessed by X-ray of the hands • Changes in DEXA of the lumbar spine and hip joints • Frequency and change in RAMRIS (MR score: synovitis, erosion, oedema, composite score) • Number of patients receiving intra-articular glucocorticosteroid injections between visit 1 – 3, 4 – 6, 7 – 16 • Cumulated dose of intra-articular glucocorticosteroid administered between visit 1 – 3, 4 – 6, 7 – 16 • Frequency and severity of adverse events including serious adverse events ;Timepoint(s) of evaluation of this end point: Secondary endpoints will be evaluated at month 4, 7, 10, 13 and 16 depending on endpoint. | — |
Countries
Denmark
Contacts
Public ContactKristian Stengaard-Pedersen
Aarhus University Hospital, Department of Rheumatology U
Outcome results
None listed