A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-017443-34-GB

Enrollment

502

Registered

2010-08-09

Start date

2010-11-01

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis MedDRA version: 12.1 Level: LLT Classification code 10002556 Term: Ankylosing spondylitis

Interventions

Trade Name: RoActemra® Product Code: Ro 487-5733/F01 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: tocilizumab

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 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 previous treatment with TNF antagonist therapy inflammatory rheumatic disease other than AS (psoriatic arthritis is allowed if patient also has definite AS as defined in inclusion criteria) 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 are naïve to treatment with 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: • Efficacy of treatment with regard to radiographic benefit and improvement of physical function over 104 weeks • 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 endpoint in part 1 and part 2 is the proportion of patients with an ASAS 20 response at week 12.	—

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 are naïve to treatment with 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: • Efficacy of treatment with regard to radiographic benefit and improvement of physical function over 104 weeks • 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 endpoint in part 1 and part 2 is the proportion of patients with an ASAS 20 response at week 12.

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Countries

Belgium, Bulgaria, Czech Republic, Germany, Italy, Lithuania, Slovakia, Spain, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026