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A Study Of RoActemra/Actemra (Tocilizumab) in Tocilizumab-Naive Patients With Rheumatoid Arthritis With Inadequate Response to Non-Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) or Biologic Therapy

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: tocilizumab [RoActemra/Actemra] (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: ML28693 www.roche.com/about_roche/roche_worldwide.htm, Phone: 888-662-6728 (U.S. Only), Email: global.rochegenentechtrials@roche.com

Summary

This two part, multi-center, open-label, single-arm study will evaluate the efficacy and safety of RoActemra/Actemra as a monotherapy or in combination with non-biologic disease modifying antirheumatic drugs (DMARDs) in patients with moderate to severe rheumatoid arthritis who have an inadequate response or are intolerant to non-biologic DMARDs or biologic therapy. 162 mg RoActemra/Actemra will be administered once a week by subcutaneous injection for up to 76 weeks.

Clinical Details

Official title: A Multicenter Open-Label Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Tocilizumab in Tocilizumab-Naive Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARD and/or Biologic Therapy

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in disease activity score 28-erythrocyte sedimentation rate (DAS28-ESR)

Secondary outcome:

Change in ACR/EULAR response

Change in disease activity (CDAI/SDAI)

Change in joint swelling/tenderness (SJC/TJC)

Incidence of adverse events

Changes in ultrasound assessment of joint inflammation (synovitis ultrasound scoring system)

Incidence of anti-therapeutic antibodies

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients > / = 18 years of age

- Patients with a diagnosis of active RA according to the revised ACR criteria or

EULAR/ACR criteria and receiving outpatient treatment

- Oral corticosteroids (< / = 10 mg/day prednisone or equivalent) nonsteroidal

anti-inflammatory drugs (NSAIDs), and permitted non-biologic DMARDs are allowed if on a stable dose regimen for > / = 20 mm/h and swollen joint count (SJC) > / = 3 (based on 44 joints)

- Inadequate response (IR) to tumor necrosis factor, Abatacept and/or non-biological

disease-modifying antirheumatic drugs (DMARDs) Exclusion Criteria:

- Major surgery (including joint surgery) within 8 weeks prior to Screening or planned

major surgery within 6 months following Baseline

- Rheumatic autoimmune disease other than RA; Secondary Sjögren's syndrome with RA is

permitted.

- Functional Class IV as defined by the ACR Classification of Functional Status in

Rheumatoid Arthritis

- Diagnosis of juvenile idiopathic arthritis or juvenile RA and/or RA before the age of

16

- Prior history of current inflammatory joint disease other than RA

- Exposure to RoActemra/Actemra at any time prior to Baseline

- Treatment with any investigational agent within 4 weeks of Screening

- Previous treatment with any cell-depleting therapies, including investigational

agents or approved therapies or any alkylating agents such as chlorambucil, or with total lymphoid irradiation

- Treatment with IV gamma globulin, plasmapheresis within 6 months of Baseline

- Intraarticular or parenteral corticosteroids within 4 weeks prior to Baseline

- Immunization with a live/attenuated vaccine within 4 weeks prior to Baseline

- History of severe allergic or anaphylactic reactions to human, humanized, or murine

monoclonal antibodies

- Serious uncontrolled concomitant disease or other significant condition

- History of diverticulitis, diverticulosis requiring antibiotic treatment, or chronic

ulcerative lower GI disease

- Current or history of recurrent bacterial, viral, fungal, mycobacterial, or other

infections

- Any infection requiring hospitalization or treatment with IV antibiotics within 4

weeks of Screening or oral antibiotics within 2 weeks of Screening

- Active TB requiring treatment within the previous 3 years

- Positive for hepatitis B or C

- Primary or secondary immunodeficiency disorder

- Active cancer, or cancer diagnosed within the previous 10 years (except for

non-melanoma skin cancer or carcinoma in situ of the cervix that has been treated of excised and is considered resolved), or breast cancer diagnosed within the previous 20 years

- History of alcohol, drug, or chemical abuse within 1 year prior to Screening

- Neuropathies or other conditions that might interfere with pain evaluation

Locations and Contacts

Reference Study ID Number: ML28693 www.roche.com/about_roche/roche_worldwide.htm, Phone: 888-662-6728 (U.S. Only), Email: global.rochegenentechtrials@roche.com

Amiens 80054, France; Active, not recruiting

Bordeaux 33076, France; Active, not recruiting

Brest 29609, France; Active, not recruiting

Caen 14033, France; Recruiting

Cahors 46005, France; Active, not recruiting

Clermont-ferrand 63003, France; Active, not recruiting

Echirolles 38434, France; Active, not recruiting

La Source 45100, France; Active, not recruiting

Le Mans 72037, France; Active, not recruiting

Lille 59037, France; Active, not recruiting

Limoges 87042, France; Active, not recruiting

Lomme 59462, France; Active, not recruiting

Lyon cedex 3 69437, France; Active, not recruiting

Marseille 13274, France; Active, not recruiting

Marseille 13274, France; Completed

Marseille 13285, France; Completed

Metz Tessy 74370, France; Active, not recruiting

Monaco 98012, France; Active, not recruiting

Montpellier 34295, France; Active, not recruiting

Mulhouse 68070, France; Active, not recruiting

Paris 75651, France; Active, not recruiting

Paris 75571, France; Active, not recruiting

Paris 75679, France; Active, not recruiting

Paris 75679, France; Completed

Paris 75877, France; Active, not recruiting

Paris 75475, France; Active, not recruiting

Rennes 35033, France; Active, not recruiting

Rouen 76031, France; Active, not recruiting

St Mande 94163, France; Active, not recruiting

St Priest En Jarez 42277, France; Completed

Strasbourg 67098, France; Active, not recruiting

Thonon Les Bains 74203, France; Active, not recruiting

Toulouse 31059, France; Active, not recruiting

Vandoeuvre-les-nancy 54511, France; Completed

Additional Information

Starting date: February 2014
Last updated: August 17, 2015

Page last updated: August 20, 2015

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