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Trial record 27 of 130 for:    GCA

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

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ClinicalTrials.gov Identifier: NCT03923738
Recruitment Status : Recruiting
First Posted : April 23, 2019
Last Update Posted : October 31, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 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 5, 2019
Estimated Primary Completion Date : August 26, 2020
Estimated Study Completion Date : August 26, 2020


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




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 ]


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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.

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): NCT03923738


Contacts
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Contact: Reference Study ID Number: WP41152 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Locations
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Switzerland
Universitätsspital Basel; Rheumatologie Recruiting
Basel, Switzerland, 4031
Inselspital Bern; Rheumatologie; Klinische Immunologie und Allergologie Recruiting
Bern, Switzerland, 3010
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03923738     History of Changes
Other Study ID Numbers: WP41152
2018-004718-17 ( EudraCT Number )
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: October 2019
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).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Polymyalgia Rheumatica
Giant Cell Arteritis
Arteritis
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases