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

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