Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - Patient comes from ending open label studies such as WELCOME -C87046, COSPAR - C87065, MUSIC - C87043, PRECISE 3 - C87033, PRECISE 4 - C87034 and C87088.
- - Patient has been treated with any experimental biological or non biological therapy other than Certolizumab Pegol (CZP) within 5 plasma half-lifes* - Has been treated with an approved biological, namely infliximab within the last 8 weeks, and adalimumab within the last 2 weeks* - Known hypersensitivity to CZP or any of its excipients.
- - Current or recent history of severe, progressive, uncontrolled renal, hepatic, haematological, gastrointestinal (other than Crohn's disease), endocrine, pulmonary, cardiac, neurological, or cerebral disease.
- - Serious or life threatening infection within the last 6 months, any signs of current or recent infection.
- - Active or latent tuberculosis (TB): if one or more of the 3 criteria is positive for evidence of TB infection*: 1.
- - Patient received live vaccinations including, but not limited to, oral polio, herpes zoster, measles-mumps-rubella (MMR) or nasal influenza within the last 8 weeks or has planned live immunizations during the planned period of administration of CZP.
- - Known prior or concurrent viral hepatitis B and C.
- - Known Human Immunodeficiency Virus (HIV) infection.
- - Concurrent malignancy or a history of malignant disease.
- - History of a lymphoproliferative disorder or any signs or symptoms suggestive of this disease.
- - History of, or suspected or confirmed active demyelinating disease of the central nervous system.
- - History of or concurrent New York Heart Association (NYHA) Class III/IV heart failure.
- - As the safety and efficacy of CZP has not been established in patients younger than 18 years of age, drug is not recommended for use in these patients until further data are available.
- - As no data are available in pregnant women, drug should not be administered to female patients of childbearing potential - unless an adequate method of contraception is used - or to pregnant/lactating female patients.
- - C87043, PRECISE 3 - C87033, PRECISE 4 - C87034 and C87088.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|UCB Biopharma S.P.R.L.|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||001 844 599 2273 (UCB)|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.