A Study of Subcutaneously Administered RoActemra/Actemra (Tocilizumab) as Monotherapy or in Combination With Methotrexate and/or Other DMARDS in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

A NATIONAL, OPEN-LABEL, SINGLE-ARM, PHASE IIIB STUDY TO EVALUATE THE EFFICACY OF WEEKLY TOCILIZUMAB SUBCUTANEOUS, ADMINISTERED AS MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE AND/OR OTHER DMARDS IN RHEUMATOID ARTHRITIS (RA) PATIENTS.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01941940
• Other study ID #: ML28699
• Secondary ID: 2013-001569-17
• Status: Recruiting
• Phase: Phase 3
• First received: September 2, 2013
• Last updated: June 1, 2015
• Start date: September 2013
• Est. completion date: May 2016

Study information

• Verified date: June 2015
• Source: Hoffmann-La Roche
• Contact: Reference Study ID Number: ML28699 www.roche.com/about_roche/roc
• Phone: 888-662-6728 (U.S. Only)
• Email: global.rochegenentechtrials[@]roche.com
• Is FDA regulated: No
• Health authority: Italy: Agenzia Italiana Del Farmaco
• Study type: Interventional

Clinical Trial Summary

This open-label, single arm study will evaluate the efficacy and safety of subcutaneously administered RoActemra/Actemra (tocilizumab), in monotherapy or in combination with methotrexate and/or other disease-modifying antirheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis. Patients will receive RoActemra/Actemra 162 mg subcutaneously weekly for at least 52 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: May 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Diagnosis of active rheumatoid arthritis (RA) according to the revised (1987) ACR criteria or EULAR/ACR (2010) criteria

• Moderate to severe RA (CDAI >/= 10 and DAS28 >/= 3.2) at screening

• Inadequate response to tumor necrosis factor inhibitors (TNF-IR), methotrexate (MTX-IR), and/or disease-modifying antirheumatic drugs (DMARD-IR)

• Oral corticosteroids (</=10 mg/day prednisone or equivalent) and non-steroidal anti-inflammatory drugs (NSAIDs; up to the maximum recommended dose) are permitted if on a stable dose regimen for >/= 4 weeks prior to baseline

• Permitted non-biologic DMARDs are allowed if at a stable dose for at least 4 weeks prior to baseline

• Receiving treatment on an outpatient basis, not including RoActemra/Actemra (tocilizumab)

• Females of childbearing potential and males with female partners of childbearing potential must agree to use a reliable means of contraception for at least 3 months following the last dose of RoActemra/Actemra

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 or current inflammatory joint disease other than RA

• Exposure to Tocilizumab (either IV or SC) at any time prior to baseline

• Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening

• Previous treatment with any cell-depleting therapies

• Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline

• History of severe allergic or anaphylactic reactions to human, humanized, or murin monoclonal antibodies

• Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine (including uncontrolled diabetes mellitus), or gastrointestinal disease

• Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections

• Any major episode of 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 surface or hepatitis C infection

• Primary or secondary immunodeficiency (history of or currently active)

• Evidence of active malignant disease, malignancies diagnosed within the previous 10 years (except for basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that has been excised and cured), or breast cancer diagnosed within the previous 20 years

• Pregnant or breast feeding women

• Neuropathies or other conditions that might interfere with pain evaluation

Study Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• DMARDs
Permitted non-biologic disease-modifying antirheumatic drugs, at a stable dose that was initiated at least 4 weeks prior to baseline, are: azathioprine, chloroquine, hydroxychloroquine, leflunomide, methotexrate, and sulfasalazine. Treatment is according to standard of care.
• tocilizumab [RoActemra/Actemra]
162 mg SC weekly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Clinical Disease Activity Index (CDAI)		from baseline to Week 24	No
Secondary	Health Assessment Questionnaire-Disability Index (HAQ-DI)		52 weeks	No
Secondary	Short Form Health & Labour Questionnaire (SF-HLQ)\n		52 weeks	No
Secondary	Functional Assessment of Chronic Illness Therapy (Fatigue FACIT-F)		52 weeks	No
Secondary	Change in Disease Activity Score (DAS28-ESR)		from baseline to Week 52	No
Secondary	Change in American College of Rheumatology (ACR) scores		from baseline to Week 52	No
Secondary	Change in European League Against Rheumatism (EULAR) criteria		from baseline to Week 52	No
Secondary	Change in Simplified Disease Activity Index (SDAI)		from baseline to Week 52	No
Secondary	Remission according to Clinical Disease Activity Index (CDAI) on two consecutive visits		52 weeks	No
Secondary	Change in Tender/Swollen Joint Count (TJC/SJC)		from baseline to Week 52	No
Secondary	Safety: Incidence of adverse events		60 weeks	No
Secondary	Incidence of anti-therapeutic antibodies		60 weeks	No
Secondary	Global Assessment/Pain visual analogue scale (PGA/Pain-VAS)		52 weeks	No