ML28096-Tapered vs stable dose with RoActemra and methotrexate in RA

• Research type

  Research Study

• Full title

  Randomised, Phase IV, placebo-controlled, comparative study to evaluate the efficacy and safety of tapering methotrexate (MTX) dosage versus maintaining the dosage in patients with severe active rheumatoid arthritis (RA) who have demonstrated an inadequate response to prior conventional disease-modifying anti-rheumatic drugs (DMARDs) treatment and have initiated RoActemra® (tocilizumab, TCZ) in combination with MTX.

• IRAS ID

  101415

• Contact name

  Andrew Ostor

• Eudract number

  2011-005260-20

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  The purpose of the study is to test whether reducing MTX dosages will result in maintained efficacy and added safety in the usage of RoActemra. This UK multicentre study will include 618 patients aged over 18 years with severe RA, who are not responding adequately to their DMARD medication, recruited from maximum 60 hospital sites. The study has two parts: open-label (the medication being taken is known by physicians and patients) in the first 24 weeks and blinded for further 32 weeks, in which neither physician nor patients knows if they are in the MTX reducing or maintaining group. At week 24 the blinded period starts, where patients achieving an optimal clinical response will be randomised to either maintaining or reducing MTX dosage. To maintain the blinding, patients will receive blinded MTX capsules, each containing active or dummy (placebo) medication at each visit. RoActemra will be given intravenously with 1 infusion every 4 weeks (total of 15 infusions). MTX will be given orally weekly. Post study medication phase, there will be a follow-up period of 4 weeks giving a total duration of 60 weeks (excluding screening). Assessments of disease activity, including joint counts, will be made by the investigator at regular intervals; the patient will complete questionnaires assessing quality of life, physical functioning, fatigue and work/ productivity impairment; patient safety will be assessed by the collection of adverse events and blood samples to check for laboratory and clinical abnormalities.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  12/EE/0176

• Date of REC Opinion

  28 Jun 2012

• REC opinion

  Further Information Favourable Opinion