RA drug access program offers continued treatment for prior study participants
NCT ID NCT03559686
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This program provides ongoing access to certolizumab pegol (Cimzia) for adults with rheumatoid arthritis who took part in earlier open-label studies. Participants receive the standard maintenance dose of 200 mg every two weeks. The goal is to allow continued disease management or a smooth transition to standard care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- certolizumab pegol (Cimzia)
- What this could lead to
- If successful, this program could help maintain disease control in people with rheumatoid arthritis who have already benefited from the drug.
- What could go wrong
- This is not a new trial but a continuation program for a limited group. It does not test new benefits or safety, and results may not apply to the wider RA population.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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: 1. A medical history of or current active tuberculosis (TB) 2. A recent (\<6 months) chest X-ray with signs consistent with TB infection 3. 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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