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Monoclonal Antibodies
Secukinumab: Polymyalgia Rheumatica (PMR) for Polymyalgia Rheumatica
Phase 1
Recruiting
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, week 4 and week 8: pre-dose and end-of infusion (eoi); weeks 9, 10, 11, 12, 16 and 20: anytime
Awards & highlights
Study Summary
This trial will look at how the drug Secukinumab is processed in the body and whether it is safe for adult patients with giant cell arteritis or polymyalgia rheumatica after receiving
Who is the study for?
Adults over 50 with Giant Cell Arteritis (GCA) or Polymyalgia Rheumatica (PMR), experiencing symptoms like severe headaches, vision loss, jaw pain when eating, and morning stiffness. Participants must have signs of active GCA not due to past damage and no other joint issues. They should also test negative for certain arthritis markers and show evidence of vasculitis on medical imaging or a temporal artery biopsy.Check my eligibility
What is being tested?
The trial is testing the safety and how well the body handles multiple doses of Secukinumab given through an IV in patients with GCA or PMR. It will track how the drug moves through and exits the body, as well as its tolerability after repeated infusions.See study design
What are the potential side effects?
Possible side effects from Secukinumab may include reactions at the infusion site, increased risk of infections due to immune system suppression, allergic reactions, headache, runny nose or sore throat.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 4 and week 8: pre-dose and end-of infusion (eoi); weeks 9, 10, 11, 12, 16 and 20: anytime
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 4 and week 8: pre-dose and end-of infusion (eoi); weeks 9, 10, 11, 12, 16 and 20: anytime
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Secukinumab: Area under the concentration-time curve at steady state during a dosing interval (AUCtau,ss)
Secukinumab: Average concentration at steady state (Cavg,ss [=AUCtau,ss/tau])
Secukinumab: Maximum concentration at steady state (Cmax,ss)
+1 moreSecondary outcome measures
Number of Participants with Treatment Emergent Adverse Events
Secukinumab: Clearance (CL)
Secukinumab: Volume of distribution at steady state (Vss)
Side effects data
From 2019 Phase 4 trial • 102 Patients • NCT0305549419%
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
Group I: Secukinumab: Polymyalgia Rheumatica (PMR)Experimental Treatment1 Intervention
Group II: Secukinumab: Giant Cell Arteritis (GCA)Experimental Treatment1 Intervention
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
2,860 Previous Clinical Trials
4,198,249 Total Patients Enrolled
6 Trials studying Polymyalgia Rheumatica
1,223 Patients Enrolled for Polymyalgia Rheumatica
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment for this research study still ongoing?
"Indeed, information on clinicaltrials.gov highlights the ongoing recruitment for this specific research endeavor. The trial was initially made public on March 15th, 2024 and had its latest modification recorded on March 12th of the same year. A total of 60 participants are sought from a single designated site."
Answered by AI
What is the collective count of participants involved in this clinical investigation?
"Indeed, as per clinicaltrials.gov data, recruitment is ongoing for this trial. The trial was first listed on March 15th, 2024 and most recently updated on March 12th, 2024. Enrollment aims to reach 60 participants at a single site."
Answered by AI
Has the FDA granted approval for Secukinumab in treating Polymyalgia Rheumatica (PMR)?
"The safety assessment by our team at Power for Secukinumab: Polymyalgia Rheumatica (PMR) is 1, as indicated by the Phase 1 trial status which suggests there is minimal existing data on both safety and efficacy."
Answered by AI
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