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

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Secukinumab (AIN457) — BIOLOGICAL
  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 — BIOLOGICAL
  Placebo was given as i.v. at baseline, week 2 and week 4, and then s.c. every 4 weeks starting at week 8.

Study Details

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.

Key Dates

Start date

Aug 30, 2011

Status verified

Feb 2017

Primary completion

Sep 9, 2015

Completion

Sep 9, 2015

Study Design

Enrollment

637 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: AIN457 10mg/kg-75mg
  Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
• Experimental: AIN457 10mg/kg-150mg
  Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
• Placebo Comparator: Placebo
  Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24

Primary Outcome Measure

Core Study: Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20) at Week 24 [ Time Frame: Week 24 ]

Locations (39)

Find similar trials in Mesa, AZ

Related Studies

• Physica System Total Knee Replacement Registry Study
  Recruiting · Limacorporate S.p.a · Rancho Mirage, California
• Maternal Autoimmune Disease Research Alliance (MADRA) Registry
  Recruiting · Duke University · Durham, North Carolina
• Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO
  PHASE1 · Recruiting · National Cancer Institute (NCI) · Birmingham, Alabama
• RA-PRO PRAGMATIC TRIAL
  PHASE3 · Recruiting · University of Alabama at Birmingham · Auburn, Alabama