Randomized, blinded, controlled study to compare the efficacy of treatment with tocilizumab with or without glucocorticoids in rheumatoid arthritis.
- Conditions
- Rheumatoid ArthritisMedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2014-004673-16-DE
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 226
- Age >= 18 years
- RA of >= 6 months duration diagnosed according to American College of Rheumatology (ACR)/European League against Rheumatology (EULAR) criteria
Track TCZ-experienced patients:
- Have received tocilizumab (TCZ) either subcutaneous (SC, 162
milligrams [mg] once a week [QW]) or intravenous (IV, 8 mg/kilogram
[kg] every 4 weeks [Q4W]) not exceeding 800 mg/dose for the
treatment of RA for at least 24 weeks prior to randomization
- Have received 5 15 mg/day of prednisone (or glucocorticoids (GCs)
equivalent) for the treatment of RA for at least 20 weeks prior to
screening
- Currently receiving 5 mg/day of oral prednisone (or GC equivalent)
at the screening visit
- Have DAS28 ESR score <=3.2 assessed 4 to 6 weeks prior to
randomization
Track TCZ-naïve patients:
- Have active RA (defined as DAS28 ESR score >3.2)
- Are considered by the investigator as inadequate responders to
conventional synthetic disease-modifying antirheumatic drug
(csDMARDs) or biologic disease-modifying antirheumatic drug
(bDMARDs). Are TCZ treatment naive or last TCZ was >12 months prior
to screening and TCZ was not discontinued due to lack of efficacy, side
effects, or any other safety reasons
- Are receiving 5-15 mg/day prednisone (or GC equivalent) for the
treatment of RA
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 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 56
- Major surgery (including joint surgery) within 8 weeks prior to
screening, or planned major surgery during the study and up to 6
months after randomization
- Pregnant women or nursing (breastfeeding) mothers
- In females of childbearing potential, a positive serum pregnancy test
at screening
- Females of childbearing potential unwilling or unable to use reliable
means of contraception during study treatment and for a minimum of 3
months after the last dose of TCZ
- Body weight of >=150 kg
- Lack of peripheral venous access
- RA of functional class IV, as defined by the ACR Classification of
Functional Status in Rheumatoid Arthritis
- Rheumatic autoimmune disease other than RA, including systemic
lupus erythematosus, mixed connective tissue disease, scleroderma,
polymyositis, or significant systemic involvement secondary to RA (e.g.,
vasculitis, pulmonary fibrosis, or Felty syndrome). Secondary Sjögren
syndrome with RA may be allowed per the discretion of the investigator
- Diagnosed with juvenile idiopathic arthritis or juvenile RA and/or RA
before the age of 16 years
- Prior or current inflammatory joint disease other than RA (e.g., gout,
Lyme disease, sero-negative spondyloarthropathy, including reactive
arthritis, psoriatic arthritis, arthropathy of inflammatory bowel disease),
or prior or current joint infections
- Previous history of primary or secondary adrenal insufficiency
- Treatment with any investigational agent (tocilizumab excepted)
within 4 weeks (or 5 half-lives of the investigational drug, whichever is
longer) of screening. Treatment with csDMARDs, other DMARDS, and/or
biologics for RA which is permanently discontinued within 5 half-lives
prior to randomization
- Previous treatment with any cell-depleting therapies, including
investigational agents or approved therapies
- Treatment with IV gamma globulin, plasmapheresis or Prosorba
column within 6 months of screening
- Intraarticular (IA) or parenteral GCs for the treatment of RA within 6
weeks prior to randomisation (within 12 weeks prior ro randomization
for intra-articular triamcinolone)
- Previous treatment with GCs for conditions other than RA, at any dose
and in any formulation used continuously for > 1 week, during the last 1
year prior to screening. Current treatment with topical GC exceeding
20% of body surface area
- Immunization with a live/attenuated vaccine within 30 days prior to
screening
- Any previous treatment with alkylating agents such as chlorambucil or
with total lymphoid irradiation
- Inadequate haematological, renal and liver functions
- Positive hepatitis B surface antigen (HBsAg) or hepatitis C virus
antibody (HCV Ab)
- History of severe allergic or anaphylactic reactions to human,
humanized, or murine monoclonal antibodies
- Evidence of current serious uncontrolled cardiovascular (including
uncontrolled hyperlipidaemia), nervous system, pulmonary (including
obstructive pulmonary disease), renal, hepatic, endocrine (including
uncontrolled diabetes mellitus) or gastrointestinal (GI) disease
- Current liver disease as determined by the investigator
- History of diverticulitis, peptic ulcer disease, diverticulosis requiring
antibiotic treatment, or chronic ulcerative lower GI disease such as
Crohn's disease, ulcerative colitis, or other symptomatic lower GI
conditions that might predispose to perforations
- Known active current or history of recurrent bacterial, viral, fungal,
mycobacte
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method