Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007201

Trial Description

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Title

An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety and Efficacy of ABP 501 in Subjects With Moderate to Severe Rheumatoid Arthritis

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this open-label study is to evaluate the long-term safety and efficacy of ABP
501.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00007201
  •   2015/09/29
  •   2014/04/11
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Secondary IDs

  •   NCT02114931  (ClinicalTrials.gov)
  •   20130258  (Amgen)
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Health Condition or Problem studied

  •   Arthritis, Rheumatoid
  •   M06 -  Other rheumatoid arthritis
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Interventions/Observational Groups

  •   Drug: ABP 501
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   III
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Primary Outcome

- Subject incidence of adverse events and serious adverse events; time frame: Up to week 72
- Clinically significant changes in laboratory values and vital signs; time frame: Up to week 72
- Incidence of anti-drug antibodies; time frame: Up to week 72

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Secondary Outcome

- ACR 20 (20% improvement in American College of Rheumatology (ACR) core set measurements at all measured time points); time frame: Up to week 70
- Disease Activity Score (DAS) 28-CRP at all timepoints; time frame: Up to week 70

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Countries of Recruitment

  •   United States
  •   Bulgaria
  •   Canada
  •   Czech Republic
  •   Germany
  •   Hungary
  •   Poland
  •   Romania
  •   Spain
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2014/04/30
  •   425
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   81   Years
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Additional Inclusion Criteria

- Subject was randomized into protocol 20120262 and has completed the week 26 visit

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Exclusion Criteria

- Subject experienced a serious adverse event (SAE) or an adverse event (AE) in the
20120262 study that could cause extension treatment to be detrimental

- Subject has completed study 20120262 but cannot be dosed within 4 weeks of the week
26 visit of study 20120262

- Current infection requiring the use of oral or intravenous antibiotics

Other Inclusion/Exclusion criteria may apply

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Addresses

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    • Amgen
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    • Amgen
    • Amgen MD 
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    • Amgen Call Center 
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    •   866-572-6436
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.