A Study With Tocilizumab [RoActemra/Actemra] Monotherapy or in Combination With Methotrexate in Patients With Rheumatoid Arthritis (PICTURE)

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01063062
First received: February 3, 2010
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

This single-arm, open-label, multicenter study will evaluate the safety and tolerability and the efficacy in reducing disease activity of tocilizumab [RoActemra/Actemra] as monotherapy or in combination with methotrexate in patients with active moderate to severe rheumatoid arthritis (RA). Patients are eligible to participate in this study if they are currently experiencing an inadequate response to a stable dose of a non-biologic DMARD. Patients will receive 8 mg/kg tocilizumab [RoActemra/Actemra] as an intravenous infusion every 4 weeks for a total of 6 infusions. The anticipated time on study treatment is 24 weeks. The target sample size is 50-200 patients.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: tocilizumab [RoActemra/Actemra]
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single-arm, Open-label, Multicenter Study of Tocilizumab Monotherapy or in Combination With Methotrexate to Assess Safety and the Efficacy in Reducing Disease Activity in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs (PICTURE)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Efficacy: Disease activity [ Time Frame: Weeks 4, 8, 12, 16, 20, 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and Tolerability: AEs [ Time Frame: AEs: throughout study until week 24 ] [ Designated as safety issue: No ]
  • Incidence of AEs and SAEs related discontinuation [ Time Frame: Throughout study until week 24 ] [ Designated as safety issue: No ]

Enrollment: 103
Study Start Date: February 2010
Study Completion Date: April 2011
Arms Assigned Interventions
Experimental: 1 Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg intravenous infusion every 4 weeks for 24 weeks (6 infusions)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients >/=18 years of age
  • Moderate to severe rheumatoid arthritis (RA) for at least 6 months (defined as a DAS28>3.2 at screening)
  • Patients with active RA after more than 12 weeks of treatment with DMARDs
  • Patients with inadequate response to a stable dose of non-biologic DMARD

Exclusion Criteria:

  • Autoimmune disease other than RA. Patients with interstitial pulmonary fibrosis and able to tolerate MTX and patients with Sjögren's Syndrome and RA are permitted
  • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
  • Prior history of or current inflammatory joint disease other than RA
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063062

Locations
Egypt
Alexandria, Egypt, 0
Banha, Egypt, 0
Cairo, Egypt, 0
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01063062     History of Changes
Other Study ID Numbers: ML22725
Study First Received: February 3, 2010
Last Updated: July 19, 2011
Health Authority: Egypt: Ministry of Health and Population

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 24, 2014