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• Research type

  Research Study

• Full title

  An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2).

• IRAS ID

  20231

• Contact name

  Bhaskar Dasgupta

• Eudract number

  2009-011137-26

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  Rheumatoid Arthritis (RA) is a chronic, progressive and disabling auto-immune disease, which is incredibly painful and can cause severe disability. Non-pharmalogical treatments are available such as physical and occupational therapy. Pharmacological treatments include painkillers, anti-inflammatory drugs and steroids, which are used to suppress the symptoms; while disease-modifying anti-rheumatic drugs (DMARDs) are required to halt the underlying immune process and prevent long-term damage. In recent times, the tumor necrosis factor antagonists have dramatically changed rheumatology practice and the benefit of using these earlier in the disease is being increasingly recognised. Subcutaneous golimumab (SC-GLM50) is a new biologic anti-TNF-alpha monoclonal antibody being tested in this trial. It is administered subcutaneously using an autoinjector, a device specifically designed for patients with RA. This is an open-label, global, multicenter, prospective trial in biologic naÇîve subjects with RA who have active disease despite taking a conventional DMARD regimen. This trial comprises two parts: Part 1 aims at studying the safety and effectiveness in inducing remission of adding SC-GLM50 to conventional DMARD treatment in subjects who are insufficiently controlled by DMARD(s). Part 2 is a randomised study to see if combining SC-GLM50 and intravenous golimumab (IVGLM2) will induce and maintain remission in subjects who showed a good response to SC-GLM50 in Part 1 but did not achieve remission. 3150 subjects will participate in part 1 and 500 subjects will go in to Part 2. This study will be conducted at approximately 500 sites in Europe, South America and South Africa.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  09/H0305/78

• Date of REC Opinion

  19 Oct 2009

• REC opinion

  Further Information Favourable Opinion