Rheumatoid Arthritis in adult MedDRA version: 13.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: Medrol 4 mg tablets
Pharmaceutical Form: Tablet
CAS Number: 83-43-2
Other descriptive name: METHYLPREDNISOLONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration n
Sponsors
N.V. Roche S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Non-interventional phase : - Male or non pregnant, non-nursing female - = 18 years of age - Diagnosis of moderate to severe active RA defined as DAS28 = 3.7 - Patients with inadequate clinical response to a current treatment with = 2 non-biologic DMARDs, 1 of them being MTX optimally administered during a period of = 3 months OR patients with inadequate clinical response to anti-TNF therapy - Start TCZ according to SmPC at Visit 1 as per the physician’s discretion - Combination therapy with MTX or without MTX in case of intolerability to MTX or where continued treatment with MTX is inappropriate - Receiving treatment on an outpatient basis - Current use of an oral GC started at least 4 weeks prior to Visit 1 - Absence of evolutive tuberculosis, demonstrated by a negative Mantoux-test (PPD) and a negative chest X-ray. A patient diagnosed with latent TB should be treated with standard prophylactic antimycobacterial TB therapy for at least 4 weeks before initiating the biologic - Patients able and willing to give written informed consent and comply with the requirements of the study protocol (non-interventional & interventional phase) Interventional phase: - Patients enrolled in the non-interventional phase - Patients in LDA defined as DAS28 score = 3.2 at Visit 2 - Oral GC use with methylprednisolone equivalent dose of = 1 mg and = 20 mg/day at Visit 2 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: For both phases : - Rheumatic autoimmune disease other than RA, incl. systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis or significant systemic involvement secondary to RA (e.g. vasculitis, pulmonary fibrosis or Felty's syndrome). Patients with interstitial pulmonary fibrosis and still able to tolerate MTX therapy are permitted. Sjögren's syndrome with RA or nodulosis is permitted - Functional class IV as defined by the ACR Classification of Functional Status in RA (largely or wholly incapacitated with patient bedridden or confided to wheel chair, permitting little or no self-care) - Prior history of or current inflammatory joint disease other than RA (e.g. gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) - Females of child-bearing potential who are not using a reliable means of contraception, e.g. physical barrier (patient and partner), contraceptive pill or patch, spermicide and barrier, or IUD - Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) prior to Visit 1 - Immunization with a live/attenuated vaccine within 4 weeks prior to Visit 1 - Treatment with opioids within 1 week prior to Visit 1 of the trial - Evidence of serious uncontrolled concomitant cardiovascular, nervous system (like myasthenia gravis), psychiatric, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus, osteoporosis) or gastrointestinal disease (ulcus pepticum) - Uncontrolled disease states, such as asthma, psoriasis or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids - Patients with a history of diverticulitis or diverticulosis requiring antibiotic treatment or chronic ulcerative lower gastro-intestinal (GI) disease such as Crohn's disease, ulcerative colitis or recent bowel anastomosis or other symptomatic lower GI conditions that might predispose to perforations - Known active current infection or history of recurrent bacterial, viral, fungal, mycobacterial or other infections including but not limited to TB - Any major episode of infection requiring hospitalization or treatment with IV antibiotics and/or GC 4 weeks before start or oral antibiotics and/or GC within 2 weeks prior to Visit 1 - Patients with active TB are excluded when treatment was required within the previous 3 years - History of alcohol, drug or chemical abuse within the 6 months prior to Visit 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Non-interventional phase: description of GC use in RA patients treated with Tocilizumab (TCZ) in daily clinical practice Intreventional phase : proportion of RA patients in low disease activity (LDA) able to discontinue oral GC within 20 weeks and at the latest at Visit 8, confirmed at the consecutive visit (Consolidation visit) without loss of clinical response defined as DAS28 (CRP) > 3.2 ;Secondary Objective: Non-interventional phase: - Proportion of patients able to reach LDA, defined as DAS28 = 3.2 and remission defined as DAS28 3.2 - RA patient able to reduce oral GC (= 50% reduction) at Visit 9 (week 24) - Time-averaged GC dose change from Visit 3 till Visit 9 (AUC method) - Change in physicians global assessment from Visit 3 to Consolidation Visit - Change in HAQ from Visit 3 to Consolidation Visit - Change in FACIT-Fatigue from Visit 3 to Consolidation Visit - Change in VAS pain from Visit 3 to Consolidation Visit - Change in SF36 mental and physical component score from Visit 3 to Consolidation Visit - Change in different SF36 sub domain scores from Visit 3 to Consolidation Visit - RA patients able to discontinue GC only by Visit 9 (week 24) Sub analyses will look at patients entering the GC dose reduction phase in DAS28 remission, with LDA, on TCZ monotherapy, those patients able to discontinue GC prior to Visit 8 (Week 20) and RA patients without GC vs those who still require GC by Visit 9. Safety endpoints - In all included patients (non-interventional and interventional phase): ? Incidence of AEs and SAEs ? Incidence of infections and serious infections - In patients included in the interventional phase: ? Patients experiencing a loss of clinical response defined as DAS28 (CRP) > 3.2 during application of GC dose reduction schedule ? Change of CRP from Visit 3 till Consolidation Visit ? Increase in swollen joint count (SJC) to 3 or more from Visit 3 till Consolidation Visit ? Increase in HAQ of ~ 0.15 from Visit 3 till Conso | — |
Countries
Belgium
Outcome results
None listed