A Study of Tocilizumab + DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00951275
First received: July 30, 2009
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

This single arm study will assess the effect of tocilizumab + DMARDs (Disease Modifying Anti-Rheumatic Drugs)on improvement of anemia and fatigue in patients with moderate to severe active rheumatoid arthritis. Eligible patients who have had an inadequate response to DMARDs will receive tocilizumab 8mg/kg iv every 4 weeks in combination with standard DMARDs, for 6 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: tocilizumab [RoActemra/Actemra]
Drug: Standard DMARDs (Disease Modifying Anti Rheumatic Drugs)
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 Study of Early Improvement of Anemia and Fatigue During Treatment With Tocilizumab (TCZ) in Combination With DMARDs, in Adult Patients With Moderate to Severe Active Rheumatoid Arthritis.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in Hb levels from baseline [ Time Frame: Day 14, 28 and every 4 weeks ] [ Designated as safety issue: No ]
  • Change in FACIT-F scale score [ Time Frame: Day 14, 28 and every 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with ACR20/50/70 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Mean change from baseline in ACR score set [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in ACR score set [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Categorical DAS28 responders [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Enrollment: 105
Study Start Date: October 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: tocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks for 6 months
Drug: Standard DMARDs (Disease Modifying Anti Rheumatic Drugs)
As prescribed

  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;
  • rheumatoid arthritis >=6 months duration;
  • DAS28>=3.2;
  • inadequate response to prior treatment with a stable dose (>=8 weeks) of DMARD therapy.

Exclusion Criteria:

  • rheumatic autoimmune disease other than rheumatoid arthritis;
  • history of or current inflammatory joint disease other than rheumatoid arthritis;
  • unsuccessful treatment with an anti-TNF agent;
  • previous/concurrent treatment with any cell-depleting therapies.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00951275

Locations
Italy
Benevento, Campania, Italy, 82100
Napoli, Campania, Italy, 80131
Scafati, Campania, Italy, 84018
Telese Terme, Campania, Italy, 82037
Bologna, Emilia-Romagna, Italy, 40138
Parma, Emilia-Romagna, Italy, 43100
Piacenza, Emilia-Romagna, Italy, 29100
Roma, Lazio, Italy, 00153
Roma, Lazio, Italy, 00189
Roma, Lazio, Italy, 00133
Viterbo, Lazio, Italy, 01100
Savona, Liguria, Italy, 17100
Bergamo, Lombardia, Italy, 24127
Monza, Lombardia, Italy, 20052
Rozzano, Lombardia, Italy, 20089
Torino, Piemonte, Italy, 10154
Brindisi, Puglia, Italy, 72100
Martina Franca, Puglia, Italy, 74015
San Cesario Di Lecce, Puglia, Italy, 73016
Catania, Sicilia, Italy, 95124
Gazzi, Sicilia, Italy, 98125
Palermo, Sicilia, Italy, 90146
Palermo, Sicilia, Italy, 90127
Massa, Toscana, Italy, 54100
Venezia, Veneto, Italy, 30127
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00951275     History of Changes
Other Study ID Numbers: ML22462, 2009-011105-17
Study First Received: July 30, 2009
Last Updated: November 7, 2013
Health Authority: Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014