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出境医 / 临床实验 / A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab (TCZ) Administered to Participants With Giant Cell Arteritis (GCA).

A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab (TCZ) Administered to Participants With Giant Cell Arteritis (GCA).

Study Description
Brief Summary:
This study will evaluate the pharmacokinetics, pharmacodynamics, and safety of two dose levels of tocilizumab (TCZ) administered by intravenous (IV) infusion every 4 weeks (Q4W) to participants with giant cell arteritis (GCA).

Condition or disease Intervention/treatment Phase
Giant Cell Arteritis Drug: Tocilizumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib, Open-Label, Dose-Ranging Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Administered by Intravenous Infusion to Patients With Giant Cell Arteritis
Actual Study Start Date : August 5, 2019
Actual Primary Completion Date : November 12, 2020
Actual Study Completion Date : November 12, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Tocilizumab
Participants will receive up to 6 doses of Dose 1 of TCZ IV Q4W followed by up to 6 doses of Dose 2 of TCZ IV Q4W.
 Drug: Tocilizumab
TCZ will be administered by IV infusion at two dose levels Q4W. The maximum dose of TCZ that will be administered is 800 mg. The dose of TCZ infusion will be calculated on the basis of body weight measured prior to each infusion.
Other Name: RoActemra/Actemra
Outcome Measures
Primary Outcome Measures :
  1. Maximum Serum Concentration (Cmax) of TCZ [ Time Frame: Days 1, 57, 85, 113, 120, 127, 134, 141, 197, 225, 253, 260, 267, 274 and 281 ]
  2. Trough Serum Concentration (Ctrough) of TCZ [ Time Frame: Days 1, 57, 85, 113, 120, 127, 134, 141, 197, 225, 253, 260, 267, 274 and 281 ]
  3. Area Under the Concentration-Time Curve over the Dosing Interval of 4 Weeks (AUC4weeks) of TCZ [ Time Frame: Days 1, 57, 85, 113, 120, 127, 134, 141, 197, 225, 253, 260, 267, 274 and 281 ]
  4. Percentage of Participants with Adverse Events [ Time Frame: From Baseline through Day 281 ]

Secondary Outcome Measures :
  1. Serum Concentration of Interleukin-6 (IL-6) [ Time Frame: On Days 1, 85, 113, 141, 225, 253 and 281 ]
  2. Serum Concentration of Soluble Interleukin-6 Receptor (sIL-6R) [ Time Frame: On Days 1, 85, 113, 141, 225, 253 and 281 ]
  3. Serum Concentration of C-Reactive Protein (CRP) [ Time Frame: At screening, Days 1, 29, 57, 85, 113, 120, 127, 134, 141, 169, 197, 225, 253, 260, 267, 274 and 281 ]
  4. Erythrocyte Sedimentation Rate (ESR) [ Time Frame: At screening, Days 1, 29, 57, 85, 113, 120, 127, 134, 141, 169, 197, 225, 253, 260, 267, 274 and 281 ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of GCA as classified according to protocol-specified criteria;
  • Participants entering Period 1 must be receiving treatment with TCZ 8 mg/kg IV Q4W.

Exclusion Criteria:

  • Treatment with any other investigational agent besides TCZ within 12 weeks (or 5 half-lives of the investigational drug, whichever is longer) prior to screening;
  • Evidence of serious uncontrolled disease;
  • Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections;
  • Active TB requiring treatment within the previous 3 years.
Contacts and Locations

Locations
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Switzerland
Universitätsspital Basel; Rheumatologie
Basel, Switzerland, 4031
Inselspital Bern; Rheumatologie; Klinische Immunologie und Allergologie
Bern, Switzerland, 3010
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
Tracking Information
First Submitted Date  ICMJE April 19, 2019
First Posted Date  ICMJE April 23, 2019
Last Update Posted Date December 10, 2020
Actual Study Start Date  ICMJE August 5, 2019
Actual Primary Completion Date November 12, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2019)
  • Maximum Serum Concentration (Cmax) of TCZ [ Time Frame: Days 1, 57, 85, 113, 120, 127, 134, 141, 197, 225, 253, 260, 267, 274 and 281 ]
  • Trough Serum Concentration (Ctrough) of TCZ [ Time Frame: Days 1, 57, 85, 113, 120, 127, 134, 141, 197, 225, 253, 260, 267, 274 and 281 ]
  • Area Under the Concentration-Time Curve over the Dosing Interval of 4 Weeks (AUC4weeks) of TCZ [ Time Frame: Days 1, 57, 85, 113, 120, 127, 134, 141, 197, 225, 253, 260, 267, 274 and 281 ]
  • Percentage of Participants with Adverse Events [ Time Frame: From Baseline through Day 281 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2019)
  • Serum Concentration of Interleukin-6 (IL-6) [ Time Frame: On Days 1, 85, 113, 141, 225, 253 and 281 ]
  • Serum Concentration of Soluble Interleukin-6 Receptor (sIL-6R) [ Time Frame: On Days 1, 85, 113, 141, 225, 253 and 281 ]
  • Serum Concentration of C-Reactive Protein (CRP) [ Time Frame: At screening, Days 1, 29, 57, 85, 113, 120, 127, 134, 141, 169, 197, 225, 253, 260, 267, 274 and 281 ]
  • Erythrocyte Sedimentation Rate (ESR) [ Time Frame: At screening, Days 1, 29, 57, 85, 113, 120, 127, 134, 141, 169, 197, 225, 253, 260, 267, 274 and 281 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab (TCZ) Administered to Participants With Giant Cell Arteritis (GCA).
Official Title  ICMJE A Phase Ib, Open-Label, Dose-Ranging Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Administered by Intravenous Infusion to Patients With Giant Cell Arteritis
Brief Summary This study will evaluate the pharmacokinetics, pharmacodynamics, and safety of two dose levels of tocilizumab (TCZ) administered by intravenous (IV) infusion every 4 weeks (Q4W) to participants with giant cell arteritis (GCA).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Giant Cell Arteritis
Intervention  ICMJE Drug: Tocilizumab
TCZ will be administered by IV infusion at two dose levels Q4W. The maximum dose of TCZ that will be administered is 800 mg. The dose of TCZ infusion will be calculated on the basis of body weight measured prior to each infusion.
Other Name: RoActemra/Actemra
Study Arms  ICMJE Experimental: Tocilizumab
Participants will receive up to 6 doses of Dose 1 of TCZ IV Q4W followed by up to 6 doses of Dose 2 of TCZ IV Q4W.
Intervention: Drug: Tocilizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 8, 2020) 		23
Original Estimated Enrollment  ICMJE
 (submitted: April 19, 2019) 		25
Actual Study Completion Date  ICMJE November 12, 2020
Actual Primary Completion Date November 12, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of GCA as classified according to protocol-specified criteria;
  • Participants entering Period 1 must be receiving treatment with TCZ 8 mg/kg IV Q4W.

Exclusion Criteria:

  • Treatment with any other investigational agent besides TCZ within 12 weeks (or 5 half-lives of the investigational drug, whichever is longer) prior to screening;
  • Evidence of serious uncontrolled disease;
  • Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections;
  • Active TB requiring treatment within the previous 3 years.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03923738
Other Study ID Numbers  ICMJE WP41152
2018-004718-17 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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