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 responseChange 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
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