Ankylosing Spondylitis MedDRA version: 12.1 Level: LLT Classification code 10002556 Term: Ankylosing spondylitis
Conditions
Interventions
Trade Name: RoActemra®
Product Code: Ro 487-533/F01
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: RO4877533
Sponsors
F. Hoffmann-La Roche Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: adult patients, >/=18 years of age diagnosis of definite ankylosing spondylitis, defined by modified New York criteria, = 3 months prior to baseline active disease defined as BASDAI score of = 4.0 and spinal pain assessment score of =40, on a 0-100 mm Visual Analogue Scale (VAS), at screening and baseline inadequate response or intolerant to 1 or more current or previous NSAIDs inadequate response or to treatment with etanercept, infliximab, adalimumab or golimumab because of inadequate efficacy (etanercept = 3 months at 25 mg twice a week or 50 mg weekly; at least 3 months of infliximab at = 5 mg/kg; adalimumab at a minimum of 40 mg every other week for = 3 months, or 4 subcutaneous injections of golimumab at 50 mg monthly). at screening, CRP greater than ULN 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: previous treatment with tocilizumab inflammatory rheumatic disease other than AS (psoriatic arthritis is allowed if patient also has definite AS as defined in inclusion criteria) total ankylosis of spine active, acute uveitis at baseline major surgery (including joint surgery) within eight weeks prior to screening or planned major surgery within six month after randomisation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the: • Efficacy of treatment with TCZ 4 mg/kg and 8 mg/kg versus placebo in AS patients who have had an inadequate response to TNF antagonist therapy with regard to the proportion of patients who achieve an ASAS20 response at week 12 (confirmation at week 24) • Safety of TCZ 4 mg/kg and 8 mg/kg versus placebo with regard to AEs and laboratory assessments;Secondary Objective: To assess the: • Long term safety and efficacy of TCZ in patients with AS • Pharmacokinetics and pharmacodynamics of TCZ in patients with AS • Immunogenicity of TCZ in patients with AS;Primary end point(s): The primary efficacy endpoint is the ASAS20 response rate at Week 12. | — |
Countries
Belgium, Bulgaria, Czech Republic, Denmark, Germany, Italy, Lithuania, Slovakia, Spain, United Kingdom
Outcome results
None listed