Tofacitinib for Reduction of Spinal Inflammation in Patients With Psoriatic ArthritiS PresenTing With Axial InvOlvement

Study Purpose

To evaluate the efficacy of Tofacitinib in reducing inflammation in the sacroiliac joints and spine on magnetic resonance imaging (MRI) in patients with active Psoriatic Arthritis (PsA) with axial Involvement (BASDAI [Bath Ankylosing Spondylitis Disease Activity Index] ≥ 4 and total backpain ≥ 4 despite treatment with NSAIDs plus evidence of active inflammation in the sacroiliac joints or spine on MRI).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Psoriatic Arthritis fulfilling ClASsification for Psoriatic ARthritis (CASPAR) criteria.

- chronic back pain > 3 months.

- BASDAI value ≥ 4 and backpain ≥ 4 / 10 VAS.

- presence of active inflammation in Screening MRI of sacroiliac joints and / or spine (central reading) - history of inadequate response to ≥ 2 NSAIDs or intolerance / contraindications.

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04062695
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Charite University, Berlin, Germany
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Denis Poddubnyy, Prof
Principal Investigator Affiliation	Charite University, Dept. Rheumatology CBF
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Germany
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Psoriatic Arthritis, Spondylitis, Sacroilitis

Additional Details

This study is a prospective, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy of Tofacitinib in reducing inflammation in the sacroiliac joints and in the spine on MRI in patients with active axial PsA. Eligible patients (n=80) will be randomized 1:1 to receive either Tofacitinib 5mg orally twice daily or placebo for a 12-week period. After week 12, all patients will receive Tofacitinib 5mg orally twice daily for another 12 weeks. The study duration will include a 6-week screening period, a 24-week treatment period and a safety follow-up period of 4 weeks. Patients will be closely monitored throughout the study on a total of 11 visits. Safety data will be collected in the form of adverse events, vital parameters, physical examinations, and laboratory parameters throughout the study. The baseline MRI of the whole spine and sacroiliac (SI) joints will be performed within the 6-week screening period to confirm the presence of active inflammation (bone marrow edema) compatible with Spondyloarthritis (will be assessed by a central reader), at week 12 to evaluate the primary study endpoint, and at week 24 to evaluate the secondary endpoint. The primary study endpoint will be an improvement of the total Berlin MRI score for sacroiliac joints and spine at week 12 as compared to baseline.

Arms & Interventions

Arms

Active Comparator: Tofacitinib

5 mg oral BID

Placebo Comparator: Placebo

matching Placebo BID

Interventions

Drug: - Tofacitinib 5 MG Oral Tablet [Xeljanz]

verum tablets

Drug: - Placebo oral tablet

tablets containing placebo

Contact a Trial Team

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International Sites

Rheumatol Schwerpunktpraxis, Berlin-Steglitz, Germany

Status

Recruiting

Address

Rheumatol Schwerpunktpraxis

Berlin-Steglitz, , 12161

Site Contact

Jan Brandt-Jürgens, PD Dr

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