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A Study of Tocilizumab and Methotrexate in Combination or as Monotherapy in Treatment-Naïve Patients With Early Rheumatoid Arthritis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01034137
First received: December 16, 2009
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

This randomized, double-blind, placebo-controlled study will compare the efficacy with regard to sustained remission and safety of tocilizumab and methotrexate, in combination or as monotherapy, in treatment-naïve patients with early rheumatoid arthritis. Patients will be randomized to receive either tocilizumab (8mg/kg iv every 4 weeks) plus weekly methotrexate (po in ascending doses), or tocilizumab (8mg/kg iv every 4 weeks) plus placebo, or methotrexate plus placebo. Anticipated time on study treatment is 2 years, and target sample size is 300.


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: tocilizumab [RoActemra/Actemra]
Drug: methotrexate
Drug: placebo TCZ
Drug: placebo MTX
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: U-ACT-EARLY: A Multi-center, Randomized, Double Blind, Placebo Controlled Study to Evaluate Remission in DMARD and Biological naïve Early Reumatoid Arthritis (RA) Subjects Treated With Tocilizumab (TCZ) Plus Tight Control Methotrexate (MTX) , TCZ Monotherapy or Tight Control MTX Monotherapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Sustained remission rate [ Time Frame: DAS28 score assessed every 4 weeks up to week 104 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression of joint damage on X-ray assessment [ Time Frame: weeks 52 and 104 ] [ Designated as safety issue: No ]
  • Clinical efficacy: ACR and EULAR response criteria [ Time Frame: assessed every 4 weeks up to week 104 ] [ Designated as safety issue: No ]
  • Safety and tolerability: AEs, laboratory parameters [ Time Frame: throughout study, laboratory parameters assessed every 4 weeks ] [ Designated as safety issue: No ]
  • VAS pain + wellbeing, functional disability, quality of life [ Time Frame: assessed every 4 weeks up to week 104 ] [ Designated as safety issue: No ]

Enrollment: 318
Study Start Date: January 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I Drug: tocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks
Drug: methotrexate
orally weekly in ascending dosages, starting at 10mg/week
Active Comparator: II Drug: tocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks
Drug: placebo MTX
orally weekly
Placebo Comparator: III Drug: methotrexate
orally weekly in ascending dosages, starting at 10mg/week
Drug: placebo TCZ
iv every 4 weeks

  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
  • early rheumatoid arthritis (disease symptoms <1 year) according to ACR criteria
  • disease activity DAS28 >2.6
  • body weight </=110kg, BMI </=36

Exclusion Criteria:

  • rheumatic autoimmune disease other than RA
  • current inflammatory joint disease other than RA
  • previous treatment with any DMARD or biologic drug used in the treatment of RA
  • intra-articular, parenteral or oral glucocorticoids used for the arthritis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034137

Locations
Netherlands
Alkmaar, Netherlands, 1815 JD
Amersfoort, Netherlands, 3818 ES
Amsterdam, Netherlands, 1056 AB
Apeldoorn, Netherlands, 7300 DS
Breda, Netherlands, 4819 EV
Delft, Netherlands, 2625 AD
Den Helder, Netherlands, 1782GZ
Emmeloord, Netherlands, 8300 GA
Gorinchem, Netherlands, 4204 AA
Gouda, Netherlands, 2803 HH
Groningen, Netherlands, 9700RB
Haarlem, Netherlands, 2035 RC
Harderwijk, Netherlands, 3844 DG
Heerlen, Netherlands, 6419 PC
Hilversum, Netherlands, 1213 HX
Hoofddorp, Netherlands, 2134 TM
Leeuwarden, Netherlands, 8934 AD
Leiden, Netherlands, 2333 ZA
Nieuwegein, Netherlands, 3430 EM
Nijmegen, Netherlands, 6522 JV
Sneek, Netherlands, 8601 ZK
Tiel, Netherlands, 4002 WP
Utrecht, Netherlands, 3584 CX
Woerden, Netherlands, 3447 GN
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: NCT01034137     History of Changes
Other Study ID Numbers: ML22497, 2009-013316-12
Study First Received: December 16, 2009
Last Updated: May 7, 2013
Health Authority: Netherlands: Dutch Health Care Inspectorate

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 May 23, 2013