Safety and Efficacy of Tofacitinib in the Treatment of NSAID Refractory Axial Spondyloarthritis:A Clinical Trial
Status:
Unknown status
Trial end date:
2018-12-31
Target enrollment:
Participant gender:
Summary
Title Efficacy and Safety of Tofacitinib in the Treatment of NSAID-Refractory Axial
Spondyloarthritis: A Clinical Trial
Background:
Axial spondyloarthritis (axSpA) is a chronic systemic inflammatory rheumatic disease
affecting mainly sacroiliac joints and spine. There are limited options for treatment.
Initial treatments are patient's education, regular physical exercise and nonsteroidal
antiinflammatory drugs(NSAID). If the patients do not respond to at least two NSAIDs in full
dosages for at least one month then it is called NSAID refractory axSpA. In these cases
biologics like-tumor necrosis factor α blockers are the options for treatment. Tofacitinib is
a new drug has been proven to be effective for treatment of rheumatoid arthritis , psoriasis
, inflammatory bowel disease and supposed to be effective in spondyloarthritis. This study is
aimed to assess the efficacy and safety of tofacitinib in NSAID refractory ax SpA with a view
to find a safe, effective and affordable treatment modality.
Method:
This open label uncontrolled clinical trial with tofacitinib will be conducted in NSAID
refractory axSpA (age >18 years) patients. Study participants will be enrolled after having
informed written consent from the outpatient department of Rheumatology, Bangabandhu sheikh
mujib medical university. Assessment of Spondyloarthritis International Society (ASAS)
criteria will be followed for diagnosis of ax SpA. Patients failing a trial of 2 different
NSAID each for at least 2 weeks with optimum dosage without response or with partial response
and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of ≥4 (range, 0-10) or
Ankylosing spondylitis disease activity score-C reactive protein(ASDAS-CRP)>2.1 will be
considered as primary entry criteria for this study.
Baseline evaluation will include Bath AS Disease Activity Index (BASDAI), Functional Index
(BASFI) , Ankylosing spondylitis disease activity score-C reactive protein(ASDASCRP) and
Ankylosing spondylitis disease activity score-erythrocyte sedimentation rate(ASDAS-ESR).
Laboratory tests like CBC, ESR, CRP, SGPT, Serum creatinine and X-ray pelvis A/P view or
X-ray both SI joints modified Ferguson veiw (to see both SI and hip joints ), HLA-B27(if
needed), CXR P/A view and MT test or Interferon Gamma Release Assay(IGRA) will be done.
After considering inclusion and exclusion criteria eligible patients will be included for
this study. All patients will be put on 5mg tofacitinib BD. NSAID and adjuvant analgesics
will be used if needed. Follow up will be done at 4th, 12th and 24th week. Response to
treatment will be evaluated by assessement of spondyloarthritis society (ASAS) response
criteria. More than 20% improvements from baseline will consider as primary response at the
end of 12th week. Those patients who will not achieve ASAS20 response at 12th week, will be
given 10 mg tofacitinib BD. Efficacy will be assessed at the end of 24th week by ASAS20,
ASAS50, ASAS70, ASDAS-ESR, ASDAS-CRP, BASDAI, Bath ankylosing spondylitis functional
index(BASFI). Adverse effects will be assesed by history, Physical examinations and
investigations.
The entire study subjects will be informed about the nature, purpose and implication of the
study as well as whole spectrum of benefits and risk of the study. Ethical clearance will be
taken from the IRB of BSMMU.