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Secukinumab for Ankylosing Spondylitis

Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 16
Awards & highlights

Study Summary

This trial is testing a new medication for people with a certain kind of arthritis. The aim is to see if it is better than existing treatments.

Eligible Conditions
  • Ankylosing Spondylitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Who Achieved an ASAS40 (Assessment of SpondyloArthritis International Society Criteria)
Secondary outcome measures
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI)
Percentage of Participants Who Achieved ASAS20 (Assessment of Spondylarthritis International Society Criteria) Partial Remission.
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Major Improvement
+8 more

Side effects data

From 2019 Phase 4 trial • 102 Patients • NCT03055494
19%
Nasopharyngitis
13%
Upper respiratory tract infection
7%
Cough
7%
Back pain
6%
Headache
4%
Aphthous ulcer
4%
Sinus congestion
4%
Gastroenteritis viral
4%
Diarrhoea
4%
Conjunctivitis
4%
Fatigue
4%
Pharyngitis streptococcal
4%
Fall
4%
Influenza
4%
Muscle strain
4%
Urinary tract infection
4%
Postoperative wound infection
4%
Anxiety
4%
Rhinorrhoea
2%
Sneezing
2%
Rash
2%
Actinic keratosis
2%
Palpitations
2%
Abdominal distension
2%
Cyst
2%
Dermatitis
2%
Pruritus
2%
Ear pain
2%
Anaemia
2%
Lacrimation increased
2%
Suicidal ideation
2%
Toothache
2%
Peripheral swelling
2%
Pyrexia
2%
Ear discomfort
2%
Influenza like illness
2%
Nausea
2%
Cellulitis
2%
Glossodynia
2%
Otitis media
2%
Cystitis
2%
Intertrigo
2%
Ligament sprain
2%
Tooth abscess
2%
Road traffic accident
2%
Hordeolum
2%
Post procedural contusion
2%
Pruritus generalised
2%
Otitis externa candida
2%
Dehydration
2%
Tonsillitis
2%
Sinusitis
2%
Ligament rupture
2%
Tinea pedis
2%
Blood pressure increased
2%
Decreased appetite
2%
Hypoglycaemia
2%
Seborrhoeic dermatitis
2%
Wound dehiscence
2%
Insomnia
2%
Muscle spasms
2%
Myalgia
2%
Productive cough
2%
Squamous cell carcinoma
2%
Oropharyngeal pain
2%
Irritability
2%
Nasal congestion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Secukinumab 300 mg
Placebo/Secukinumab 300 mg

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SecukinumabExperimental Treatment1 Intervention
Secukinumab intravenous (i.v.) regimen
Group II: PlaceboPlacebo Group1 Intervention
Placebo intravenous (i.v.) regimen
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Secukinumab
2015
Completed Phase 4
~22170

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,196,823 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other clinical trials that have used Secukinumab?

"Secukinumab was first studied in 2014 at Attikon Hospital. Out of the 18349 completed clinical trials, 28 are ongoing with a sizable number taking place in Everett, Washington."

Answered by AI

Are new participants being sought for this clinical trial?

"Unfortunately, this clinical trial is not currently looking for patients that match your profile. However, 69 other trials for spondylarthritis and 28 trials involving Secukinumab are still recruiting."

Answered by AI

Do the risks of Secukinumab exceed the benefits?

"There is some evidence suggesting that Secukinumab is effective and multiple rounds of data supporting its safety, so it received a score of 3."

Answered by AI

How many volunteers are needed for this research project?

"As of February 21st, 2022 this study is no longer recruiting patients. Originally, the clinical trial was posted on December 11th, 2019. For other studies similar to this one, 69 trials are actively enrolling spondylarthritis patients and 28 trials are searching for Secukinumab participants."

Answered by AI

To what extent has Secukinumab been effective in treating different medical conditions?

"Not only can secukinumab be used to treat ankylosing spondylitis, but it is also effective in managing other diseases such as enthesitis related arthritis (era), psoriatic arthritis, and severe plaque psoriasis."

Answered by AI

Are there a lot of these types of trials going on in our state currently?

"Currently, there are 36 sites where this trial is enrolling patients. A few of these locations include Everett, The Woodlands and Lansing. If you choose to enroll in the trial, it may be helpful to select a location nearest to you so that you can limit your travel requirements."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study to Demonstrate the Efficacy, Safety and Tolerability of an Intravenous Regimen of Secukinumab Compared to Placebo in Subjects With Active axSpA
2019. "Study to Demonstrate the Efficacy, Safety and Tolerability of an Intravenous Regimen of Secukinumab Compared to Placebo in Subjects With Active axSpA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04156620.
~99 spots leftby Apr 2025
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