Active Nonradiographic Axial Spondylitis
Conditions
Interventions
Approximately 390 participants will be randomized in approximately 85 sites. The sample size of the study can be increased to approximately 480 participants if the number of participants with inadequa
Drug
Sponsors
CPCLIN - CENTRO DE PESQUISAS CLINICAS LTDA
Janssen-Cilag Farmacêutica Ltda.
Eligibility
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Research participants should be between 18 and 50 years of age.Rresearch participants should be classified as having NR AxSpA, based on the ASAS criteria 2009.Must present diagnostic nr-AxSpA, according to the criteria of 2009 ASAS, for 5 years.Must be 45 years old at onset of nr-AxSpA .In selection or within 3 months of selection, research participants are to present active inflammation on MRI highly suggestive of sacroiliitis associated with spondyloarthritis and should not present radiographic sacroiliitis that meets the 1984 (New York criteria modified as confirmed by an X-ray rated by central readers ) .Must present symptoms of active disease at screening and at baseline, as evidenced by both BASDAI score 4 as by a score of VAS 4 of total back pain, each on a scale of 0 to 10.Must present an inadequate response to at least two NSAIDs over a period of 4 weeks, in total, with the maximum doses recommended NSAID (s) or be unable to receive a full period of 4 weeks of treatment with most NSAIDs because of intolerance, toxicity or contraindications for NSAIDs.Research participants previously treated with an anti-TNF biologic agent must be: primary or secondary responders to at most one anti-TNF agent or intolerance present documented maximum one anti-TNF treatment or have discontinued at most 1 anti-TNF agent due to lack of efficacy / safety .IF are using other NSAIDs or analgesics for nr-AxSpA, research participants should be receiving a stable dose for at least 2 weeks prior to first administration of study drug. If are not currently using NSAIDs or other analgesics for nr-AxSpA, research participants must not have received NSAIDs or other analgesics for nr-AxSpA for at least 2 weeks prior to first administration of the drug estudo.If are using corticosteroids oral, research participants should be receiving a stable dose equivalent to 10 mg of prednisone / day for at least 2 weeks prior to first administration of the study drug .If currently are not using corticosteroids, the research participants must not have received oral corticosteroids for at least 2 weeks prior to first administration of the study drug .If are using methotrexate, sulfasalazine or hydroxychloroquine, research participants should have started treatment at least 3 months prior to the first dose of study drug and should not present no serious toxic side effects attributable to these DMARDs.
Exclusion criteria
Exclusion criteria: Present radiographic sacroiliitis that meets the 1984 New York modified criteria. Present other inflammatory diseases that may confound the ratings of the benefit of treatment with ustekinumab, including, among others: rheumatoid arthritis, systemic lupus erythematosus or Lyme. Women that is pregnant, breastfeeding or planning a pregnancy or man that bear a child in a woman during inclusion in the study or within 5 months after receiving the last dose of the study drug .Have received any systemic immunosuppressant or DMARD other than MTX, SSZ or HCQ within 4 weeks before the first administration of the study drug .Have received leflunomide within 3 months before first dose of study medication or receiving leflunomide within 12 months prior to first administration of study drug and not having undergone a drug elimination procedure.Have received corticosteroids epidural, intra-articular, IM or IV, including adrenocorticotropic hormone during 4 weeks prior to the first administration of the study drug .Have ustekinumab or any other agent whose target is IL-23.Have prior received more than one anti-TNF agent .Have received infliximab or biosimilar infliximab within 12 weeks before the first administration of the study drug.Have received adalimumab, golimumab, certolizumab pegol. etanercept within 6 weeks prior to the first administration of the study drug .Have received prior biological treatment other than anti-TNF before the first dose of the study drug .Have ever received tofacitinibe or any other inhibitor of Janus quinases.Present any known hypersensitivity to human protein immunoglobulin .Have used citotoxics drugs .Present a history of active granulomatous disease before selection.Have received vaccination with Bacillus Calmette-Guérin within the 12 months prior to selection .Present a chest radiograph within the previous 3 months the first dose of study drug to show a suggestive abnormality of malignancy or current active infection, including TB. Have presented a mycobacterial nontuberculous infection or oportunist infection.Have received, or is expected to receive any vaccination with alive virus or alive bacteria in the 3 months prior to the first administration of study medication during the study or within 3 months after the last administration of the study drug .Present one history of joint prosthesis infected or have received antibiotics for a suspected prosthetic joint infection. have presented a serious infection or have been hospitalized because of an infection or have been treated with IV antibiotics for an infection within the two months prior to the first administration of study drug. Presenting a history of infectious disease or current infectious disease, chronic or recurrent. Research participant present a history of positivity for antibodies to HIV or tested positive for HIV in selection. Present infection for Hepatitis B.Research Participantes who are positive for antibodies to hepatitis C.Present signs or current symptoms of kidney disease, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurological, brain or severe psychiatric, progressive or not controled. Present a known history of lymphoproliferative disease. The research participant presents a history of malignancy within 5 years prior to selection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) 20 Score at Week 24 - The ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants in 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20 percent (%) improvement from baseline and an absolute change >= 10 units on a 0-10 scale (0=no disease activity; 10=high disease activity) for >= 3 domains, and no worsening in remaining domain. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants Achieving ASAS 40 at Weeks 24 - The ASAS 40 = 40% improvement from baseline and an absolute change >= 20 units on a 0-10 scale (0=no disease activity, 10=high disease activity) for >= 3 domains, and no worsening in remaining domain;;Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response - The BASDAI is participant assessment of discomfort, pain and fatigue measured using a 10 centimeter Visual Analog Scale (VAS); range: 0=none to 10=very severe. BASDAI 50 response is defined as at least a 50 percent (%) improvement (decrease) from baseline to observation in the BASDAI score. Baseline score minus score at observation divided by Baseline score * 100 should be >=50%;;Percentage of Participant Who Achieve ASDAS (CRP) Inactive Disease ( 3.5). | — |
Countries
Argentina, Australia, Belgium, Brazil, Czech Republic, France, Germany, Mexico, Netherlands, Russian Federation, Spain, Taiwan, Ukraine, United Kingdom
Contacts
Public ContactVinicius Righi
Janssen-Cilag Farmacêutica Ltda.
Outcome results
None listed