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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03923738

Recruitment Status Completed

First Posted April 23, 2019

Last update posted December 10, 2020

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:Giant Cell Arteritis
  • Intervention/Treatment: Drug: Tocilizumab
  • Phase: Phase 1
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 23 participants
  • 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 2019
  • Actual Primary Completion Date: November 2020
  • Actual Study Completion Date: November 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.
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
  • 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
Contacts
Locations

Switzerland
Universitätsspital Basel; Rheumatologie
Basel

Switzerland
Inselspital Bern; Rheumatologie; Klinische Immunologie und Allergologie
Bern

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials Hoffmann-La Roche

More Information
  • Responsible Party: Hoffmann-La Roche
  • ClinicalTrials.gov Identifier: NCT03923738 History of Changes
  • Other Study ID Numbers: WP41152, 2018-004718-17
  • First Posted: April 23, 2019 Key Record Dates
  • Last Update Posted: December 10, 2020
  • Last Verified: December 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • 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).
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Polymyalgia Rheumatica
    Giant Cell Arteritis
    Arteritis