SPIRIT H2H: Ixekizumab versus Adalimumab in Psoriatic Arthritis
Research type
Research Study
Full title
A 52-Week Multicenter, Randomized, Open-Label, Parallel-Group Study Evaluating the Efficacy and Safety of Ixekizumab versus Adalimumab in Patients with Psoriatic Arthritis who are Biologic Disease-Modifying Anti-Rheumatic Drug Naïve
IRAS ID
223700
Contact name
Hasan Tahir
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2016-004585-25
Duration of Study in the UK
1 years, 8 months, 0 days
Research summary
Psoriatic Arthritis (PsA) is a chronic inflammatory disorder that occurs when the immune system mistakenly attacks healthy joints and skin. This causes painful inflammation in and around the joints, as well as red, scaly rash on the skin. PsA is progressive and destructive, and can result in bone deformaties, impaired physical function and loss of quality of life. We don't yet know exactly what causes PsA however research suggests that an infection, injury or trauma could trigger the onset and that it tends to run in families.
There is no cure for PsA but treatment with a NSAID (nonsteroidal anti-inflammatory drug) or DMARD (disease-modifying antirheumatic drug) can reduce pain, swelling and stiffness. Initial treatment is usually with a conventional DMARD (cDMARD) such as Methotrexate. Patients with an inadequate response or untolerable side-effects, can then be treated with a biologic DMARD (bDMARD).
bDMARDs are newer drugs that target one of the specific proteins that are responsible for the inflammation. Some bDMARDs, for example adalimumab, target the TNF (tumour necrosis factor) protein whereas another group of bMARDs target the Interleukin (IL) proteins, for example ixekizumab.
Ixekizumab is a humanized monoclonal antibody that blocks IL-17 proteins reducing inflammation. It has been approved for the treatment of moderate-to-severe psoriasis worldwide however to date, no results of a head-to-head study comparing 2 bDMARDs have been published.
RHCF is a randomized, open-label trial that will enrol 550 patients globally to compare the efficacy and safety of ixekizumab compared to adalimumab in the treatment of PsA. Eligible patients must have a documented diagnosis of PsA for at least 6 months, have at least 3 swollen joints and 3 tender joints and have not recieved previous treatment with bDMARDs. Patients will receive study treatment for 52 weeks and assessments will include physical examinations, questionnaire completion and blood tests.
REC name
London - Fulham Research Ethics Committee
REC reference
17/LO/0794
Date of REC Opinion
28 Jun 2017
REC opinion
Further Information Favourable Opinion