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Monoclonal Antibodies

Pharmacokinetics of certolizumab pegol for Axial Spondyloarthritis (CHERISH Trial)

Phase 1

Waitlist Available

Research Sponsored by UCB Biopharma S.P.R.L.

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 predose and postdose czp concentrations in pregnancy trimester 1,2,3 (up to 40 weeks) and postpartum (up to 13 weeks after delivery)

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the effects of certolizumab pegol, a medication that reduces inflammation, in pregnant women with chronic inflammatory diseases. The goal is to see how the drug affects both the mother and baby during pregnancy and to ensure it is safe. The medication works by blocking a protein that causes inflammation. Certolizumab pegol has been shown to have minimal to no transfer to the baby, making it a promising treatment during pregnancy.

Eligible Conditions

Axial Spondyloarthritis
Plaque Psoriasis
Rheumatoid Arthritis
Crohn's Disease
Ankylosing Spondylitis
Psoriatic Arthritis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ predose and postdose czp concentrations in pregnancy trimester 1,2,3 (up to 40 weeks) and postpartum (up to 13 weeks after delivery)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~predose and postdose czp concentrations in pregnancy trimester 1,2,3 (up to 40 weeks) and postpartum (up to 13 weeks after delivery)

This trial's timeline: 3 weeks for screening, Varies for treatment, and predose and postdose czp concentrations in pregnancy trimester 1,2,3 (up to 40 weeks) and postpartum (up to 13 weeks after delivery) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Predose and Postdose Plasma Certolizumab Pegol (CZP) Concentrations in Women During Pregnancy, Relative to Postpartum

Secondary study objectives

Number of Participants With Anti-certolizumab Pegol (CZP) Positive Antibodies Throughout the Study Period

Number of Participants With Pregnancy Outcome

Percentage of Participants With Adverse Events From Time of Informed Consent (Screening) Through Safety Follow-up (SFU)

Side effects data

From 2023 Phase 1 trial • 22 Patients • NCT04163016

40%

COVID-19

20%

Headache

13%

Nasopharyngitis

13%

Mastitis

13%

Hypertension

13%

Postpartum haemorrhage

13%

Migraine

Dyspepsia

Dizziness

Heart rate increased

Gestational diabetes

Sinusitis

Anxiety disorder

Respiratory syncytial virus infection

Arthritis

Haemorrhage

Illness

Procedural dizziness

Gastrointestinal infection

Foetal death

Colitis

Chills

Pyrexia

Cystitis

Rhinorrhoea

Hyponatraemia

Muscle spasms

Perineal injury

Oropharyngeal pain

Fatigue

Ligament sprain

Anaemia of pregnancy

Retained placenta or membranes

Hypokalaemia

Premature rupture of membranes

Inflammatory bowel disease

Cough

Uterine contractions abnormal

Female genital tract fistula

Basal cell carcinoma

100%

80%

60%

40%

20%

Study treatment Arm

CZP 200 mg Q2W

Not Dosed

CZP 400 mg Q4W

CZP 400 mg Q2W

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pharmacokinetics SamplingExperimental Treatment1 Intervention

This study will include pregnant women who have decided to continue treatment with commercial certolizumab pegol (CZP) in accordance with their treating physician prior to participating in the study. Study participants will be responsible for obtaining and administering commercially available CZP under the care of their physician and according to the locally approved product label. From all study participants blood samples will be drawn for pharmacokinetics during the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pharmacokinetics of certolizumab pegol

2020

Completed Phase 1

~30

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