Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFα Agents
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Secukinumab (AIN457); Placebo
Intervention description: AIN457 (Secukinumab) is a human monoclonal antibody. Secukinumab binds and reduces the activity of Interleukin 17 (IL- 17). AIN457 was given as i.v. (10mg/kg) at baseline, week 2 and week 4, and then s.c. (75 or 150mg) every 4 weeks starting at week 8.; Placebo was given as i.v. at baseline, week 2 and week 4, and then s.c. every 4 weeks starting at week 8.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 637.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; RA; ACR; inflammatory joints

Summary:

      The core and extension studies assessed the safety and efficacy of secukinumab when added to
      a background therapy in patients with active rheumatoid arthritis who are intolerant to or
      have had an inadequate response to anti-TNF-α agents. Patients received either secukinumab,
      placebo. The core study was completed. However, the extension study was terminated early
      (unrelated to safety) due to the results of study AIN457F2309, which indicated the efficacy
      of AIN457 was not comparable to the currently available RA treatment, abatacept, thus leading
      to closing of the AIN457 RA program.
    

Eligibility criteria:

        Inclusion criteria:

          -  Male or non-pregnant, non-lactating female patients

          -  Presence of RA classified by American College of Rheumatology (ACR) 2010 revised
             criteria for at least 3 months before screening

          -  At Baseline: Disease activity criteria defined by ≥ 6 tender joints out of 68 and ≥6
             swollen joints out of 66 with at least 1 of the following at screening:

          -  Anti-Cyclic Citrullinated Peptide (CCP) antibodies positive OR

        Rheumatoid Factor positive and with at least 1 of the following at screening:

          -  High sensitivity C-reactive protein (hsCRP) ≥ 10 mg/L OR Erythrocyte sedimentation
             rate (ESR) ≥ 28 mm/1st hr

          -  Patients must have been taking at least one anti-TNF-α agent given at an approved dose
             for at least 3 months before randomization and have experienced an inadequate response
             to treatment or have been intolerant to at least one administration of an anti-TNF-α
             agent

          -  Patients must be taking MTX for at least 3 months before randomization and have to be
             on a stable dose at least 4 weeks before randomization (7.5 to 25 mg/week For Japan
             only: 6 to 25 mg/week)

        Exclusion criteria:

          -  Chest x-ray with evidence of ongoing infectious or malignant process, obtained within
             3 months prior to screening and evaluated by a qualified physician RA patients
             functional status class IV according to the ACR 1991 revised criteria

          -  Patients who have ever received biologic immunomodulating agents except for those
             targeting TNFα

          -  Previous treatment with any cell-depleting therapies including but not limited to
             anti-CD20, investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3,
             anti-CD19)

          -  Other protocol-defined inclusion/exclusion criteria may apply.