Drug: Certolizumab Pegol
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) .
Other Name: Cimzia
- 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
- 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
+1 844 599 2273
001 844 599 2273 (UCB)
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