Rheumatoid ArthritisNCT03559686
Named Patient Program With Certolizumab Pegol in Adults Suffering From Rheumatoid Aarthritis (RA)
A study testing Certolizumab Pegol in people with Rheumatoid Arthritis, run by UCB Biopharma SRL.
Trial summary
The objective of this Named Patient Program (NPP) is to provide continued availability of Certolizumab Pegol (CZP) to adult Rheumatoid Arthritis (RA) patients who participated in the open label studies C87015 (CDP870 015), C87028 (CDP870-028) and C87051 (CDP870-051). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Certolizumab Pegol
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Has/will complete(d) one of the Certolizumab Pegol (CZP) open-label studies (C87015, C87028, C87051)
- Is currently taking CZP (last dose within the last 6 weeks for subjects from C87015, and within the last 4 weeks for subjects from C87028 or C87051)
- Is informed of the details of this Named Patient Program (NPP), is given ample time and opportunity to ask questions in order to consider his/her participation in this NPP and has provided verbal consent to participate, and, if applicable according to local regulations, has given his/her written informed consent for participation
Who cannot join
- Has been treated with any experimental biological or nonbiological therapy other than CZP within 5 plasma half-lives
- Current safety concerns for continuing an CZP therapy related to prior biologic therapy (eg, insufficient wash out period, unresolved adverse events, unresolved recovery of peripheral B-cell/lymphocyte levels following therapy with B-cell depleters)
- Has 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
- Serious or life-threatening infection within the last 6 months, including any herpes zoster infection, and/or 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:
- A medical history of or current active tuberculosis (TB)
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- A recent (<6 months) chest X-ray with signs consistent with TB infection
- A recent (<6 months) positive purified protein derivative (PPD) skin test (defined as induration or 5 mm or more) and/or an indeterminate or positive QuantiFERON-TB Gold or Elispot test.
- Patients must be monitored at least annually for active and latent TB by both 1) a chest X-ray read by a pulmonologist or radiologist and 2) a PPD skin test and/or Elispot/ QuantiFERON TB Gold test.
- Concurrent known acute or chronic viral hepatitis B or C infection
- Concurrent 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
- Current or recent history of severe, progressive, uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease
About this study
Official title: Named Patient Program With Certolizumab Pegol in Adults Suffering From Rheumatoid Arthritis (RA) Who Participated in Open Label Studies C87015, C87028 and C87051
The objective of this Named Patient Program (NPP) is to provide continued availability of Certolizumab Pegol (CZP) to adult Rheumatoid Arthritis (RA) patients who participated in the open label studies C87015 (CDP870 015), C87028 (CDP870-028) and C87051 (CDP870-051). Physicians may use the option to continue offering patients CZP treatment or to transition patients off CZP to a standard care regimen.
Read the detailed description
The Expanded Access program was not conducted and is not intended to be conducted in the United States.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Certolizumab Pegol
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Certolizumab PegolDrug
Also called Cimzia
The recommended maintenance dose of Cimzia® (Certolizumab Pegol) for adult patients with Rheumatoid Arthritis (RA) is 200 mg every 2 weeks (single 1 mL injection of 200 mg) .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559686
- Sponsor's protocol ID
- RA0039
- Status last verified
- May 2026
- First submitted
- 5 Jun 2018
- Last updated
- 1 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Named Patient Program With Certolizumab Pegol in Adults Suffering From Rheumatoid Arthritis (RA) Who Participated in Open Label Studies C87015, C87028 and C87051
- ClinicalTrials.gov ID
- NCT03559686
- Acronym / sponsor ID
- RA0039
- Conditions
- Rheumatoid Arthritis
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- First posted
- 18 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this Named Patient Program (NPP) is to provide continued availability of Certolizumab Pegol (CZP) to adult Rheumatoid Arthritis (RA) patients who participated in the open label studies C87015 (CDP870 015), C87028 (CDP870-028) and C87051 (CDP870-051). Physicians may use the option to continue offering patients CZP treatment or to transition patients off CZP to a standard care regimen.
Detailed description
The Expanded Access program was not conducted and is not intended to be conducted in the United States.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Has/will complete(d) one of the Certolizumab Pegol (CZP) open-label studies (C87015, C87028, C87051)
- Is currently taking CZP (last dose within the last 6 weeks for subjects from C87015, and within the last 4 weeks for subjects from C87028 or C87051)
- Is informed of the details of this Named Patient Program (NPP), is given ample time and opportunity to ask questions in order to consider his/her participation in this NPP and has provided verbal consent to participate, and, if applicable according to local regulations, has given his/her written informed consent for participation
Key exclusion criteria (16 listed)
- Has been treated with any experimental biological or nonbiological therapy other than CZP within 5 plasma half-lives
- Current safety concerns for continuing an CZP therapy related to prior biologic therapy (eg, insufficient wash out period, unresolved adverse events, unresolved recovery of peripheral B-cell/lymphocyte levels following therapy with B-cell depleters)
- Has 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
- Serious or life-threatening infection within the last 6 months, including any herpes zoster infection, and/or 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Certolizumab PegolAlso: CimziaThe recommended maintenance dose of Cimzia® (Certolizumab Pegol) for adult patients with Rheumatoid Arthritis (RA) is 200 mg every 2 weeks (single 1 mL injection of 200 mg) . | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
001 844 599 2273 (UCB)
Questions about this trial
What is this clinical trial studying?
A study testing Certolizumab Pegol in people with Rheumatoid Arthritis, run by UCB Biopharma SRL.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.