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.
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 (
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