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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03559686
Expanded Access Status : Available
First Posted : June 18, 2018
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Study Description
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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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: Certolizumab Pegol

Study Design
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Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.
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

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Interventions
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Intervention Details:
  • 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03559686


Contacts
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Contact: UCB Cares +1 844 599 ext 2273 UCBCares@ucb.com

Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
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Study Director: UCB Cares 001 844 599 2273 (UCB)
More Information
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Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT03559686    
Other Study ID Numbers: RA0039
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
 Immune System Diseases
Certolizumab Pegol
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents