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Monoclonal Antibodies
Certolizumab pegol for Rheumatoid Arthritis
Phase 1
Waitlist Available
Research Sponsored by UCB Biopharma SRL
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant must be 18 to 69 years of age inclusive, at the time of signing the informed consent
Participant must have a diagnosis of moderately-to-severely active rheumatoid arthritis (RA)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose (day 0), day 7, 14, 42, 70, 72, 75, 77, 80, 84, 126, and 168
Awards & highlights
Study Summary
This study is evaluating whether a drug may help treat rheumatoid arthritis.
Eligible Conditions
- Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ predose (day 0), day 7, 14, 42, 70, 72, 75, 77, 80, 84, 126, and 168
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose (day 0), day 7, 14, 42, 70, 72, 75, 77, 80, 84, 126, and 168
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area Under the Concentration-time Curve Over One Dosing Interval (AUC0-tau) of Certolizumab Pegol
Minimum Observed Plasma Concentration (Cmin) Post 10 Weeks of Certolizumab Pegol Dosing
Secondary outcome measures
Percentage of Participants With Treatment-emergent Adverse Event (TEAEs) Leading to Withdrawal
Percentage of Participants With Treatment-emergent Serious Adverse Event (SAEs)
Plasma Concentration of Certolizumab Pegol (CZP) During the Study
Side effects data
From 2011 Phase 4 trial • 333 Patients • NCT0058084013%
Upper respiratory tract infection
8%
Urinary tract infection
3%
Rheumatoid arthritis
3%
Arthralgia
2%
Nasopharyngitis
1%
Cellulitis
1%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Run-in Overall
Certolizumab Pegol 400 mg and Placebo + Methotrexate
Certolizumab Pegol 200 mg and Placebo + Methotrexate
Placebo + Methotrexate
Trial Design
1Treatment groups
Experimental Treatment
Group I: Certolizumab pegolExperimental Treatment1 Intervention
Subjects in this arm will receive doses of certolizumab pegol for the treatment of Rheumatoid Arthritis, in accordance with the US label.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Certolizumab pegol
2008
Completed Phase 4
~3160
Find a Location
Who is running the clinical trial?
UCB Biopharma SRLLead Sponsor
101 Previous Clinical Trials
21,384 Total Patients Enrolled
2 Trials studying Rheumatoid Arthritis
22 Patients Enrolled for Rheumatoid Arthritis
UCB CaresStudy Director001 844 599 2273 (UCB)
203 Previous Clinical Trials
44,329 Total Patients Enrolled
10 Trials studying Rheumatoid Arthritis
3,651 Patients Enrolled for Rheumatoid Arthritis
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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