Study Estimating the Clinical Difference Between 300 mg and 150 mg of Secukinumab Following Dose Escalation to 300 mg in Patients With Ankylosing Spondylitis

Conditions

• Ankylosing Spondylitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 150 mg open-label secukinumab — DRUG
  All patients in Treatment Period 1 received 150 mg s.c. injection open-label secukinumab.
• 150 mg double-blinded secukinumab — DRUG
  Treatment Period 2 Patients who achieved responder status entered Treatment Period 2 and continued to receive 150 mg s.c. (1 s.c. injection of secukinumab 150 mg)
• 300 mg double-blinded secukinumab — DRUG
  Treatment Period 2 300 mg (2 s.c. injections of the 150 mg dose)

Study Details

This was a study estimating the clinical difference between 300 mg and 150 mg of secukinumab following dose escalation to 300 mg in patients with ankylosing spondylitis

Key Dates

Start date

Mar 13, 2018

Status verified

Apr 2022

Primary completion

Mar 11, 2021

Completion

May 29, 2021

Study Design

Enrollment

322 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Responders
  Patients who achieved an Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease (total score \<1.3) at both Week 12 and Week 16.
• Active Comparator: Inadequate responders
  Patients who have active disease, defined as an Ankylosing Spondylitis Disease Activity Score (ASDAS) total score of \>1.3 at both Week 12 and Week 16, and who achieved a decrease (improvement) from baseline in total ASDAS score at both Week 12 and Week 16.
• Active Comparator: Non-responders
  Patients who exhibit no change or an increase (worsening) from baseline in total Ankylosing Spondylitis Disease Activity Score (ASDAS) score at either Week 12 or Week 16. Non-responders were not entered Treatment Period 2. Non-responders were discontinued from the study at Week 16.

Primary Outcome Measure

The Proportion of Participants Who Achieved Inactive Disease Based on the Ankylosing Spondylitis Disease Activity Score (ASDAS) Measure [ Time Frame: Week 52 ]

Locations (65)

Find similar trials in Jonesboro, AR

Related Studies

• Testing of an Educational Tool for Patients With Melanoma and Pre-Existing Autoimmune Disease Who Are Candidates for Immune Checkpoint Inhibitors
  Recruiting · M.D. Anderson Cancer Center · Houston, Texas
• Exactech Shoulder Post Market Clinical Follow-up Study
  Recruiting · Exactech · Laguna Woods, California
• IMPACT - AndHealth Autoimmune Research Registry
  Recruiting · AndHealth · Columbus, Ohio
• Rheumatology Diet Study
  Recruiting · University of Central Florida · Orlando, Florida