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A Study of RoActemra/Actemra (Tocilizumab) in Patients With Giant Cell Arteritis

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Giant Cell Arteritis

Intervention: prednisone (Drug); prednisone placebo (Drug); tocilizumab [RoActemra/Actemra] (Drug); tocilizumab [RoActemra/Actemra] (Drug); tocilizumab [RoActemra/Actemra] (Drug); tocilizumab placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Overall contact:
Reference Study ID Number: WA28119 www.roche.com/about_roche/roche_worldwide.htm, Phone: 888-662-6728 (U.S. Only), Email: global.rochegenentechtrials@roche.com

Summary

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with giant cell arteritis. Patients will be randomized to receive either RoActemra/Actemra 162 mg subcutaneously weekly or every 2 weeks or placebo for 52 weeks, with tapering oral daily doses of prednisone. After Week 52, patients in remission will stop study treatment and enter long-term follow-up, whereas patients with disease activity or flares will receive open-label RoActemra/Actemra 162 mg subcutaneously weekly for a maximum period of 104 weeks at the discretion of the investigator. Anticipated time on study is 39 months.

Clinical Details

Official title: A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Proportion of patients in sustained remission at Week 52 (TCZ + 26 weeks prednisone taper versus placebo + 26 weeks prednisone taper)

Secondary outcome:

Proportion of patients in sustained remission at Week 52 (TCZ + 26 weeks prednisone taper versus placebo + 52 weeks prednisone taper)

Time to giant cell arteritis disease flare after clinical remission (TCZ + 26 weeks prednisone taper versus placebo + 26 and 52 weeks prednisone taper)

Total cumulative prednisone dose (TCZ + 26 weeks prednisone taper versus placebo + 26 and 52 weeks prednisone taper)

Patient reported outcome: Short form SF-36 questionnaire (TCZ + 26 weeks prednisone taper versus placebo + 26 and 52 weeks prednisone taper)

Patient reported outcome: Patient global assessment (PGA) of disease activity on visual analogue scale (VAS) (TCZ + 26 weeks prednisone taper versus placebo + 26 and 52 weeks prednisone taper)

Pharmacokinetics: Area under the concentration-time curve (AUC) of tocilizumab in combination with 26 week tapering prednisone

Pharmacokinetics: Tocilizumab concentrations in combination with 26 week tapering prednisone (Cmin, Cmax, Ctrough)

Pharmacodynamics: Interleukin 6/sIL-6R/ESR/CRP

Safety: Incidence of adverse events

Incidence of anti-tocilizumab antibodies

Eligibility

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of giant cell arteritis classified according to the following criteria:

- Age >/= 50 years

- History of ESR >/= 50 mm/hour

- and at least one of the following:

- Unequivocal cranial symptoms of giant cell arteritis

- Symptoms of polymyalgia rheumatica

- and at least one of the following

- Temporal artery biopsy revealing features of giant cell arteritis

- Evidence of large-vessel vasculitis

- New onset active disease (diagnosis within 6 weeks of baseline) or refractory active

disease (diagnosis > 6 weeks before baseline and previous treatment with >/= 40 mg/day prednisone (or equivalent) for at least 2 consecutive weeks at any time); active disease defined as presence of clinical signs and symptoms and ESR >/= 30 mm/hour or CRP >/= 1 mg/dl within 6 weeks of baseline Exclusion Criteria:

- Recent or incoming major surgery

- Organ transplantation recipient (except corneas within 3 months prior to baseline

visit)

- Major ischemic event, unrelated to giant cell arteritis, within 12 weeks of screening

- Prior treatment with any of the following:

- Investigational agent within 12 weeks (or 5 half-lives of the investigational

drug, whichever is longer) of screening visit

- Cell-depleting agents (e. g. anti CD 20)

- Tocilizumab

- Tofacitinib

- Alkylating agents including CYC within 6 months of baseline

- HCQ, CsA, AZA, or MMF within 4 weeks of baseline

- Tumor necrosis factor inhibitors within 2-8 weeks of baseline

- Anakinra within 1 week of baseline

- Corticosteroids for conditions other than GCA

- IV corticosteroids within 6 weeks of baseline

- History of severe allergic reactions to monoclonal antibodies

- Evidence of serious uncontrolled concomitant disease (e. g. cardiovascular,

respiratory, renal, endocrine)

- Current liver disease that could interfere with the trial as determined by the

investigator

- History of diverticulitis, inflammatory bowel disease, or other symptomatic GI tract

condition that might predispose to bowel perforation

- Infections:

- Active current or history of recurrent bacterial, viral fungal, mycobacterial,

or other infection

- Prior episode of major infection

- Active TB requiring treatment within the previous 3 years

- Untreated latent TB infection (LTBI)

- Primary or secondary immunodeficiency

- Malignancy (except for basal and squamous cell carcinoma of the skin or carcinoma in

situ of the cervix uteri that has been excised and cured)

- Inadequate hematologic, renal or liver function

- Positive for hepatitis B or hepatitis C infection

Locations and Contacts

Reference Study ID Number: WA28119 www.roche.com/about_roche/roche_worldwide.htm, Phone: 888-662-6728 (U.S. Only), Email: global.rochegenentechtrials@roche.com

Graz 8036, Austria; Terminated

Bruxelles 1070, Belgium; Active, not recruiting

Leuven 3000, Belgium; Active, not recruiting

Liège 4000, Belgium; Terminated

Hillerod 3400, Denmark; Terminated

Odense C 5000, Denmark; Terminated

Bobigny 93009, France; Active, not recruiting

Bondy 93143, France; Terminated

Brest 29609, France; Active, not recruiting

Lille 59037, France; Active, not recruiting

Marseille 13000, France; Active, not recruiting

Mulhouse 68070, France; Active, not recruiting

Paris 75571, France; Terminated

Paris 75679, France; Active, not recruiting

Bad Abbach 93077, Germany; Active, not recruiting

Bad Bramstedt 24576, Germany; Active, not recruiting

Baden-Baden 76530, Germany; Terminated

Berlin 10117, Germany; Active, not recruiting

Berlin 14059, Germany; Active, not recruiting

Dresden 01307, Germany; Active, not recruiting

Erlangen 91054, Germany; Active, not recruiting

Frankfurt 60596, Germany; Terminated

Freiburg 79106, Germany; Active, not recruiting

Hannover 30625, Germany; Active, not recruiting

Herne 44652, Germany; Completed

Jena 07747, Germany; Active, not recruiting

Kiel 24105, Germany; Active, not recruiting

Mainz 55131, Germany; Active, not recruiting

Muenchen 80336, Germany; Active, not recruiting

Plochingen 73207, Germany; Active, not recruiting

Stuttgart 70376, Germany; Terminated

Tübingen 72076, Germany; Active, not recruiting

Amsterdam 1081 HV, Netherlands; Active, not recruiting

Arnhem 6815 AD, Netherlands; Active, not recruiting

Groningen 9700 RB, Netherlands; Active, not recruiting

Hengelo 7555 DL, Netherlands; Active, not recruiting

Nijmegen 6525 GA, Netherlands; Active, not recruiting

Førde 6800, Norway; Terminated

Kristiansand 4604, Norway; Active, not recruiting

Oslo 0027, Norway; Active, not recruiting

Trondheim 7006, Norway; Recruiting

Ålesund N-6026, Norway; Active, not recruiting

Bydgoszcz 85-168, Poland; Active, not recruiting

Szczecin 71-252, Poland; Active, not recruiting

Lisboa 1050-34, Portugal; Terminated

Porto 4099-001, Portugal; Active, not recruiting

Barcelona 08907, Spain; Active, not recruiting

Barcelona 8036, Spain; Active, not recruiting

Goteborg 413 45, Sweden; Active, not recruiting

Lund 221 85, Sweden; Active, not recruiting

Malmo 205 02, Sweden; Active, not recruiting

Stockholm 171 76, Sweden; Active, not recruiting

Uppsala 751 85, Sweden; Active, not recruiting

Aberdeen AB25 2ZN, United Kingdom; Active, not recruiting

Barnsley S75 2EP, United Kingdom; Active, not recruiting

Birmingham B15 2TH, United Kingdom; Active, not recruiting

Colchester, Essex CO4 5JL, United Kingdom; Recruiting

Edinburgh EH16 4TJ, United Kingdom; Active, not recruiting

Ipswich IP4 5PD, United Kingdom; Terminated

Kirkcaldy KY1 2ND, United Kingdom; Terminated

Leeds LS7 4SA, United Kingdom; Active, not recruiting

London EC1V 2PD, United Kingdom; Active, not recruiting

Newcastle Upon Tyne NE7 7DN, United Kingdom; Active, not recruiting

Romford RM7 0AG, United Kingdom; Active, not recruiting

Stoke-on-trent ST6 7AG, United Kingdom; Completed

Truro TR1 3LJ, United Kingdom; Active, not recruiting

Westcliffe-on-sea SS0 0RY, United Kingdom; Active, not recruiting

Paradise Valley, Arizona 85253, United States; Active, not recruiting

Los Angeles, California 90025, United States; Active, not recruiting

Los Angeles, California 90048, United States; Active, not recruiting

Reggio Emilia, Emilia-Romagna 42100, Italy; Active, not recruiting

Boca Raton, Florida 33486, United States; Active, not recruiting

Sarasota, Florida 34239, United States; Active, not recruiting

Tampa, Florida 33612-4799, United States; Recruiting

Udine, Friuli-Venezia Giulia 33100, Italy; Active, not recruiting

Gainesville, Georgia 30501, United States; Terminated

Chicago, Illinois 60612, United States; Recruiting

Wichita, Kansas 67207, United States; Terminated

Paducah, Kentucky 42003, United States; Active, not recruiting

A Coruna, La Coruña 15006, Spain; Active, not recruiting

Santiago de Compostela, La Coruña 15706, Spain; Terminated

Genova, Liguria 16132, Italy; Active, not recruiting

Milano, Lombardia 20132, Italy; Active, not recruiting

Pavia, Lombardia 27100, Italy; Terminated

Portland, Maine 04102, United States; Active, not recruiting

Baltimore, Maryland 21224, United States; Not yet recruiting

Boston, Massachusetts 02114, United States; Active, not recruiting

St. Claire Shores, Michigan 48081, United States; Active, not recruiting

Minneapolis, Minnesota 55455, United States; Terminated

Rochester, Minnesota 55905, United States; Active, not recruiting

Lake Success, New York 11042, United States; Terminated

New York, New York 10016, United States; Terminated

New York, New York 10021, United States; Active, not recruiting

Asheville, North Carolina 28803, United States; Active, not recruiting

Hamilton, Ontario L8N 2B6, Canada; Not yet recruiting

Toronto, Ontario M5G 1X5, Canada; Terminated

Philadelphia, Pennsylvania 19104, United States; Active, not recruiting

Trois-rivieres, Quebec G8Z 1Y2, Canada; Active, not recruiting

La Laguna, Tenerife 38320, Spain; Active, not recruiting

Austin, Texas 78758, United States; Recruiting

Houston, Texas 77004, United States; Recruiting

Firenze, Toscana 50141, Italy; Terminated

Pisa, Toscana 56126, Italy; Active, not recruiting

Prato, Toscana 59100, Italy; Active, not recruiting

Salt Lake City, Utah 84132, United States; Active, not recruiting

Padova, Veneto 35128, Italy; Active, not recruiting

Verona, Veneto 37126, Italy; Active, not recruiting

Bilbao, Vizcaya 48013, Spain; Active, not recruiting

Vancouver, Washington 98604, United States; Active, not recruiting

Wausau, Wisconsin 54401, United States; Active, not recruiting

Additional Information

Starting date: July 2013
Last updated: August 17, 2015

Page last updated: August 23, 2015

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