Named Patient Program With Certolizumab Pegol in Adults Suffering From Rheumatoid Aarthritis (RA)

This is an expanded access trial for Rheumatoid Arthritis Read More

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