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
Brief 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). Physicians may use the option to continue offering patients CZP treatment or to transition patients off CZP to a standard care regimen.

Individual Patients
Rheumatoid Arthritis

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

Eligibility Criteria

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

- 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

- 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

Eligibility Gender
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A

UCB Cares
+1 844 599 - 2273

UCB Cares, Study Director
001 844 599 2273 (UCB)

UCB Biopharma SRL
NCT Number
MeSH Terms
Arthritis, Rheumatoid
Certolizumab Pegol