Axial Spondyloarthritis
Conditions
Brief summary
This is a phase IV, multicentre, randomized, double-blind, placebo-controlled study designed to compare the efficacy and safety of tofacitinib versus placebo (on a background of an NSAID) over 16 weeks of treatment and 4 weeks of safety follow-up in subjects with early active axSpA and inadequate response to at least one NSAID, with objective signs of inflammation.
Interventions
DRUGTofacitinib 5 MG
Patients receive Tofacitinib and Naproxene
Sponsors
Pfizer
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
multicentre, randomized, double-blind, placebo-controlled study
Intervention model description
This is a phase IV, multicentre, randomized, double-blind, placebo-controlled study designed to compare the efficacy and safety of tofacitinib versus placebo (on a background of an NSAID) over 16 weeks of treatment and 4 weeks of safety follow-up in subjects with early active axSpA and inadequate response to at least one NSAID, with objective signs of inflammation
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of axSpA and fulfilment of the ASAS classification criteria * Symptom (back pain) duration for ≤ 2 years, according to the definition of early axial SpA by ASAS. * Active disease activity as defined by: BASDAI ≥4 and back pain score (BASDAI question 2) of ≥4 AND objective signs of inflammation evident by osteitis in MRI of SIJ AND/OR elevated serum CRP levels.
Exclusion criteria
* active current infection, severe infections in the last 3 months * history of recurrent Herpes zoster or disseminated Herpes simplex * immunodeficiency * chronic Hepatitis B, C or HIV infection * women: pregnant or lactating (have to practice reliable method of contraception) * other severe diseases conflicting with a clinical study, contraindications for MRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Main trial endpoint | 16 weeks | Proportion of subjects achieving disease remission defined as Ankylosing Spondylitis Disease Activity Score (ASDAS)CRP\<1.3 at week 16 from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the MRI SIJ SPARCC osteitis score at week 16 | 16 weeks | Change from baseline in the MRI SIJ SPARCC osteitis score at week 16 |
Countries
Germany
Contacts
Primary ContactHildrun Haibel, PD Dr. med.
Backup ContactValeria Rios-Rodriguez, Dr. med.
Outcome results
None listed