A Study of RoActemra/ Actemra (Tociliumab) in Patients With Ankylosing Spondylitis Who Have Failed Treatment

Phase 2

• Conditions: Health Condition 1: M459- Ankylosing spondylitis of unspecified sites in spineHealth Condition 2: null- Spondylitis Ankylosing

• Registration Number: CTRI/2011/04/001666
• Lead Sponsor: F Hoffman La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 502

Inclusion Criteria

Adult patients greater than or equal to 18 years of age

- Ankylosing Spondylitis as defined by the modified New York criteria for greater than or equal to 3 months prior to baseline

- Active disease at screening and baseline (BASDAI greater than or equal to 4.0, spinal pain VAS greater than or equal to 40)

- Inadequate response or intolerant to 1 or more previous non-steroidal anti-rheumatic drugs (NSAIDs)

- Traditional disease-modifying anti-rheumatic drugs (DMARDs) must be withdrawn for at least 4 weeks prior to baseline (methotrexate, sulfasalazine and hyroxychloroquine or chloroquine may be allowed if at stable dose for at least 4 weeks prior to baseline)

- Oral corticosteroids (greater than or equal to 10 mg/day prednisone or equivalent) and NSAIDs/COX-2 inhibitors must be at stable dose for at least 4 weeks prior to baseline

Exclusion Criteria

- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after randomization

- Total ankylosis of spine (as determined by investigator)

- Inflammatory rheumatic disease other than ankylosing spondylitis

- Active, acute uveitis at baseline

- Treatment with TNF antagonist therapy at any time prior to baseline

- Intra-articular or tendon injections or parenteral corticosteroids within 4 weeks prior to screening

- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies

- Active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infection

- History of or currently active primary or secondary immunodeficiency

- Body weight 150 kg

Study & Design

• Study Type: Interventional
• Study Design: Not specified