[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

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Study’s contact

Call center

888-662-6728 (U.S. Only)

Email address

global.rochegenentechtrials@roche.com

Condition

Rheumatoid Arthritis

Treatment type

Interventional

Investigational product

DMARDs

Phase

Phase 3

Sponsor

Hoffmann-La Roche

ClinicalTrials.gov identifier

NCT01941940

Study number

ML28699

Date first posted

September 2, 2013

Date last update

June 1, 2015

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About the study

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.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria
  1. Adult patients, >/= 18 years of age
  2. Diagnosis of active rheumatoid arthritis (RA) according to the revised (1987) ACR criteria or EULAR/ACR (2010) criteria
  3. Moderate to severe RA (CDAI >/= 10 and DAS28 >/= 3.2) at screening
  4. Inadequate response to tumor necrosis factor inhibitors (TNF-IR), methotrexate (MTX-IR), and/or disease-modifying antirheumatic drugs (DMARD-IR)
  5. 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
  6. Permitted non-biologic DMARDs are allowed if at a stable dose for at least 4 weeks prior to baseline
  7. Receiving treatment on an outpatient basis, not including RoActemra/Actemra (tocilizumab)
  8. 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
  1. Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline
  2. Rheumatic autoimmune disease other than RA; secondary Sjögren's syndrome with RA is permitted
  3. Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis
  4. Diagnosis of juvenile idiopathic arthritis or juvenile RA and/or RA before the age of 16
  5. Prior history of or current inflammatory joint disease other than RA
  6. Exposure to Tocilizumab (either IV or SC) at any time prior to baseline
  7. Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening
  8. Previous treatment with any cell-depleting therapies
  9. Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
  10. History of severe allergic or anaphylactic reactions to human, humanized, or murin monoclonal antibodies
  11. Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine (including uncontrolled diabetes mellitus), or gastrointestinal disease
  12. Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections
  13. 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
  14. Active TB requiring treatment within the previous 3 years
  15. Positive for hepatitis B surface or hepatitis C infection
  16. Primary or secondary immunodeficiency (history of or currently active)
  17. 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
  18. Pregnant or breast feeding women
  19. Neuropathies or other conditions that might interfere with pain evaluation

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

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