Psoriatic ArthritisPhase 2PASTORNCT04062695
Tofacitinib for Reduction of Spinal Inflammation in Patients With Psoriatic ArthritiS PresenTing With Axial InvOlvement
A Phase 2 study testing Tofacitinib 5 MG Oral Tablet [Xeljanz] in people with Psoriatic Arthritis and Spondylitis, run by Charite University, Berlin, Germany at 19 sites in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriatic Arthritis, Spondylitis, Sacroilitis
- What is being tested?
- Tofacitinib 5 MG Oral Tablet [Xeljanz]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 19 sitesGermany
- Study dates
- 4 Aug 2020to Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
19 sites in 1 country.
19 sites in 1 country
Germany19 sites, 19 recruiting
- Recruiting
Charite University, Rheumatology CCM
Berlin, 10117
Sandra Hermann, Dr
- Recruiting
Praxis für Rheumatologie
Berlin, 12163
Kirsten Karberg, Dr
- Recruiting
Charite University - Dept. Rheumatology CBF
Berlin, 12203
Deni Poddubnyy, Prof
- Recruiting
University Cologne, Dept. Rheumatology
Cologne, 50937
David Kofler, PD
- Recruiting
Uniklinik, Forschungszentrum Rheumatologie
Düsseldorf, 40225
Philipp Severin, Dr
- Recruiting
Praxis Dilltal
Ehringshausen, 35630
Mirko Steinmüller, Dr
- Recruiting
Uniklinikum, Med. Klinik 3
Erlangen, 91054
Andreas Ramming, Dr
- Recruiting
CIRI Zentrum f innovative Diagnsotik und Therapie
Frankfurt am Main, 60590
Frank Behrens, Dr
- Recruiting
Uniklinikum, Dept. Rheumatologie
Freiburg im Breisgau, 79106
Stephanie Finzel, Dr
- Recruiting
Hamburger Rheumaforschungszentrum
Hamburg, 22391
Hauke Heintz, Dr
- Recruiting
Rheumazentrum Ruhrgebiet
Herne, 44649
Uta Kiltz, PD
- Recruiting
Uniklinik, Rheumatologie
Kiel, 24105
Bimba Hoyer, Prof
- Recruiting
Klinikum Ludwigshafen, Rheumatologie
Ludwigshafen, 67063
Raoul Bergner, Prof
- Recruiting
Rheumapraxis Dr. Sieburg
Magdeburg, 39104
Maren Sieburg, Dr
- Recruiting
Inst. f Präventive Medizin & Klinische Forschung
Magdeburg, 39110
Rüdiger Möricke, Prof
- Recruiting
Uniklinikum, I. Med. Klinik
Mainz, 55131
Andreas Schwarting, Prof
- Recruiting
Praxis Prof. Kellner
München, 80935
Herbert Kellner, Prof
- Recruiting
Rheumatol Schwerpunktpraxis
Steglitz, 12161
Jan Brandt-Jürgens, PD Dr
- Recruiting
KH St. Josef, Dept. Rheumatology
Wuppertal, 42105
Astrid Thiele, Dr
About this study
Official title: Efficacy of Tofacitinib in Reduction of Inflammation Detected on MRI in Patients With Psoriatic ArthritiS PresenTing With Axial InvOlvement - a Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial
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).
Read the detailed description
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.
- Conditions
- Psoriatic Arthritis, Spondylitis, Sacroilitis
- Being tested
- Tofacitinib 5 MG Oral Tablet [Xeljanz], Placebo oral tablet
- Keywords
- Psoriatic Arthritis, Sacroiliitis, Spondylitis, MRI
- Medical subject headings
- Arthritis, Psoriatic, Spondylitis, Sacroiliitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tofacitinib 5 MG Oral Tablet [Xeljanz]Drug
Also called Xeljanz
verum tablets
Placebo oral tabletDrug
tablets containing placebo
| Study group | Role | What they receive |
|---|---|---|
| Tofacitinib | Active comparator | 5 mg oral BID Receives: Drug: Tofacitinib 5 MG Oral Tablet [Xeljanz] |
| Placebo | Placebo comparator | matching Placebo BID Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI Berlin Score
Improvement of the Berlin MRI score for sacroiliac joints and spine. Scoring includes spinal inflammation (Lucas C et al, J Rheumatol 2007): 23 vertebral units with semiquantitative range of inflammation between 0 to 3 (min. score = 0, max. score = 69, the higher the worse). Additionally, inflammation of the sacroiliac joints is scored (Hermann KG, Rheumatologe 2004; scoring each quadrant between 0 and 4, max. score 16, the higher, the worse).
Measured: Week 12 vs Baseline
Secondary outcomes (15)
The Assessment of Spondyloarthritis International Society (ASAS) response criteria
Assessment of Spondyloarthritis International Society Response Criteria (Anderson JJ, Arthritis Rheum 2001): change in percent of at least 3 of 4 subcores (Patient Global VAS, Pain VAS, BASFI and BASDAI questions 5\&6).
Measured: Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12
Responses in ASAS Health Index
Assessment of Spondyloarthritis International Society ASAS Health Index (Kiltz U, Ann Rheum Dis 2015). Consisting of 17 questions answered, calculated in percent (100 % = best spondylarthritis related health).
Measured: Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12
Responses in ASDAS
Ankylosing Spondylitis Disease Activity Score (ASDAS) combining 3 questions VAS (back pain, peripheral pain and morning stiffness) with CRP or ESR; formulas used as described in Lucas C, Ann Rheum Dis 2009. Values <1.3 inactive disease, <2.1 low disease activity, 2.1-3.5 high disease activity, >3.5 very high disease activity.
Measured: Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12
Responses in BASDAI
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Calculated score from 6 questions VAS; range 0-10, the higher the worse.
Measured: Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12
Responses in BASFI
Bath Ankylosing Spondylitis Functional Index (BASFI). Mean of 10 questions VAS, range 0-10; higher value = more impaired function.
Measured: Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12
Responses in BASMI(lin)
Bath Ankylosing Spondylitis Metrology Index - linear score (BASMI; van der Heijde Ann Rheum Dis 2008). Measuring Schober´s test (cm), intermalleolar distance (cm), cervical rotation (degree), lateral lumbar flexion (cm) and tragus-to-wall-distance (cm) and calculate the score as reported in the citation.
Measured: Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12
Responses in HAQ-DI
Health assessment questionnaire disability index (HAQ-DI; Princus T, Arthritis Rheum 1983) measuring influence of arthritis on quality of life. Patient questionnaire recalculated in scores 0 to 3, higher = worse.
Measured: Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12
Responses in Patient Global Score
Patient Global Score of overall disease activity - VAS 0-10 (higher = worse)
Measured: Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12
Responses in Physician Global Score
Physician Global Score of overall disease activity - VAS 0-10 (higher = worse).
Measured: Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12
Responses in DAPSA
Disease Activity in PSoriatic Arthritis (DAPSA; Schoels M, Arthritis Rheum 2010); calculated by summing swollen joint count (max. 66) + tender joint count (max. 68) + patient pain VAS + patient global assessments VAS + CRP. Value ranges 0 to >28 (the higher, the worse).
Measured: Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12
Responses in PASI
Psoriasis Area and Severity Index (PASI) - description of skin involvement regarding scaling, redness, thickness and body surface area. Range 0-72.
Measured: Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12
Responses in MASES
Maastricht Ankylosing Spondylitis Enthesitis Score (MASES;Heuft-Dorenbosch Ann Rheum Dis 2003). Assessing 13 clinical enthesial sites (yes / no). Range 0-13.
Measured: Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12
Response in CRP
C-reactive protein (CRP, mg per litre)
Measured: Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12
Response in ESR
Erythrocyte Sedimentation Rate (ESR, mm per 1 hour)
Measured: Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12
MRI Berlin Score
Improvement of the Berlin MRI score (description see primary outcome) for sacroiliac joints and spine
Measured: Week 24 vs Baseline, Week 24 vs Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start4 Aug 2020
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo controlled parallel group for 12 weeks followed by 12 weeks open label
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denis Poddubnyy, Charite University, Berlin, Germany
- Investigators
- Denis Poddubnyy, Prof, Principal investigator, Charite University, Dept. Rheumatology CBF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062695
- Sponsor's protocol ID
- PASTOR2018
- Acronym
- PASTOR
- Status last verified
- Jul 2022
- First submitted
- 14 May 2019
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Proft F, Torgutalp M, Muche B, Rios Rodriguez V, Verba M, Poddubnyy D. Efficacy of tofacitinib in reduction of inflammation detected on MRI in patients with Psoriatic ArthritiS presenTing with axial involvement (PASTOR): protocol of a randomised, double-blind, placebo-controlled, multicentre trial. BMJ Open. 2021 Nov 16;11(11):e048647. doi: 10.1136/bmjopen-2021-048647.
PubMed 34785545
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tofacitinib in Reduction of Inflammation Detected on MRI in Patients With Psoriatic ArthritiS PresenTing With Axial InvOlvement - a Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial
- ClinicalTrials.gov ID
- NCT04062695
- Acronym / sponsor ID
- PASTOR / PASTOR2018
- Conditions
- Psoriatic Arthritis, Spondylitis, Sacroilitis
- Keywords
- Psoriatic Arthritis, Sacroiliitis, Spondylitis, MRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 20 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Placebo controlled parallel group for 12 weeks followed by 12 weeks open label
| Arm | Type | Receives |
|---|---|---|
| Tofacitinib | Active comparator | Drug: Tofacitinib 5 MG Oral Tablet [Xeljanz]5 mg oral BID |
| Placebo | Placebo comparator | Drug: Placebo oral tabletmatching Placebo BID |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tofacitinib 5 MG Oral Tablet [Xeljanz]Also: Xeljanzverum tablets | Drug | Tofacitinib |
| Placebo oral tablettablets containing placebo | Drug | Placebo |
Primary outcome
MRI Berlin Score
Time frame: Week 12 vs Baseline
Improvement of the Berlin MRI score for sacroiliac joints and spine. Scoring includes spinal inflammation (Lucas C et al, J Rheumatol 2007): 23 vertebral units with semiquantitative range of inflammation between 0 to 3 (min. score = 0, max. score = 69, the higher the worse). Additionally, inflammation of the sacroiliac joints is scored (Hermann KG, Rheumatologe 2004; scoring each quadrant between 0 and 4, max. score 16, the higher, the worse).
15 secondary outcomes
The Assessment of Spondyloarthritis International Society (ASAS) response criteria
Time frame: Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12
Responses in ASAS Health Index
Time frame: Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12
Responses in ASDAS
Time frame: Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12
Responses in BASDAI
Time frame: Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12
Responses in BASFI
Time frame: Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12
Responses in BASMI(lin)
Time frame: Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12
Responses in HAQ-DI
Time frame: Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12
Responses in Patient Global Score
Time frame: Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12
Responses in Physician Global Score
Time frame: Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12
Responses in DAPSA
Time frame: Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12
Responses in PASI
Time frame: Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12
Responses in MASES
Time frame: Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12
Response in CRP
Time frame: Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12
Response in ESR
Time frame: Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12
MRI Berlin Score
Time frame: Week 24 vs Baseline, Week 24 vs Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Derived from this study: PubMed 34785545Proft F, Torgutalp M, Muche B, Rios Rodriguez V, Verba M, Poddubnyy D. Efficacy of tofacitinib in reduction of inflammation detected on MRI in patients with Psoriatic ArthritiS presenTing with axial involvement (PASTOR): protocol of a randomised, double-blind, placebo-controlled, multicentre trial. BMJ Open. 2021 Nov 16;11(11):e048647. doi: 10.1136/bmjopen-2021-048647.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis Poddubnyy, Prof principal investigator
Charite University, Dept. Rheumatology CBF
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tofacitinib 5 MG Oral Tablet [Xeljanz] in people with Psoriatic Arthritis and Spondylitis, run by Charite University, Berlin, Germany at 19 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabian N Proft, MD (+49-30-450 ext. 514582, fabian.proft@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI Berlin Score (time frame: Week 12 vs Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04062695, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.