Psoriatic ArthritisPhase 3PsOLSET-BDNCT03736161
Safety and Efficacy of Tofacitinib vs Methotrexate in the Treatment of Psoriatic Arthritis
A Phase 3 study testing Group A- Tofacitinib and Group B- Methotrexate in people with Psoriatic Arthritis, run by Globe Pharmaceuticals Limited at 1 site in Bangladesh.
Trial summary
Title Safety and Efficacy of Tofacitinib vs Methotrexate in the treatment of Psoriatic Arthritis- An Open Label Randomized single center study Psoriatic arthritis is defined as an inflammatory arthropathy associated with skin psoriasis and usually negative for rheumatoid factor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Group A- Tofacitinib and Group B- Methotrexate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteBangladesh
- Study dates
- 15 Sep 2017to 28 Sep 2019
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients more than 18 years
- Psoriatic arthritis > 3 months with peripheral involvement diagnosed on the basis of CASPAR criteria
- Unresponsive to more than 2 NSAIDs at maximum recommended doses for more than 4 weeks, i.e 2 weeks for each NASID
- 5. Patients with active disease 6. PsA with or without extra-articular features like enthesitis, dactylitis and nail changes
Who cannot join
- Systemic infections requiring hospital admission during the past 6 months
- A history of active infectious disorders (including active or latent tuberculosis), and/or a history of chronic or recurrent serious infective diseases, opportunistic infections
- Hemoglobin (Hb) < 9 g/dl
- White blood cell count < 3000, Neutrophil count < 1000, Platelet count < 100000
- Live vaccines within 3 months prior to the first dose
- Serum creatinine > upper limit of normal reference range
Show all 12Show fewer
- GFR less than 50 mL/min
- Alanine aminotransaminase (ALT) more than 2 times of ULN
- Pregnant or breast feeding, females of child-bearing potential not using highly effective contraception
- New York Heart Association Class III and IV congestive heart failure
- Evidence or history of malignancy, with the exception of adequately treated or excised non-metastatic basal or squamous cell cancer of the skin or cervical carcinoma in situ
- Any lymphoproliferative disorder, history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease
Trial locations and contacts
1 site in 1 country.
About this study
Title Safety and Efficacy of Tofacitinib vs Methotrexate in the treatment of Psoriatic Arthritis- An Open Label Randomized single center study Psoriatic arthritis is defined as an inflammatory arthropathy associated with skin psoriasis and usually negative for rheumatoid factor. Till date, many NSAIDs, corticosteroids, DMARDs have been used, but the safety and efficacy issues demands more researches. The prevalence of PsA worldwide is about 1%-2% and among patients with psoriasis ranges from 7% to 42%. The pathogenesis of PsA involves many cytokines. Tofacitinib is an oral Janus Kinase (JAK) inhibitor with immunomodulatory and anti-inflammatory mechanism. It binds to JAK and prevents the activation of the JAK-signal transducers and activators of transcription (STAT) signaling pathway which ultimately decreases the production of pro-inflammatory cytokines, and prevents both inflammatory response and the inflammation-induced damage. It has shown better efficacy in many diseases like Rheumatoid Arthritis, Axial spondyloarthropathies, Psoriasis, Psoriatic Arthritis, Alopecia areata, dry eye disease.
This prospective, open label, randomized study will be conducted in inpatient and outpatient departments of Rheumatology, BSMMU, Dhaka, Bangladesh in 110 adult volunteers (>18 years) of both genders diagnosed as psoriatic arthritis. Patients will be divided equally into two groups, Group A will be put on Tofacitinib 5 mg twice daily and Group B will be put on Methotrexate weekly in increasing dose with maximum dose of 25 mg weekly. Groups will be divided on the basis of randomization by random number table. Patients with inadequate response to highest dose of MTX or Tofacitinib 5 mg BD at the end of 3 months will be put on Tofacitinib 5 mg BD or Tofacitinib 10 mg BD respectively. The patients not eligible for therapy will not be included in the study. Patients will be followed up at 1, 3 and 6 months. Baseline characteristics will be monitored and recorded at 3 and 6 months.
The clinical information of the study subjects will be recorded in a structured history, clinical examination and questionnaire. All subjects will be enrolled after having informed written consent. The participants will enjoy every right to participate or withdraw from the study at any point of time. Response to Tofacitinib will be expressed in mean, standard deviation and percentage. Ethical clearance will be taken from the Institutional Review Board (IRB) of BSMMU.
Read the detailed description
Background:
Methotrexate, an anti-folate drug, is a widely accepted and commonly used DMARD for the treatment of PsA. Tofacitinib is a JAK inhibitor, and relatively new drug for this condition.
Aims:
To assess and compare safety and efficacy of Tofacitinib and Methotrexate in the treatment of PsA.
Methodology:
This open label, randomized, prospective study was conducted in Department of Rheumatology, BSMMU, Dhaka for 1½ years from September, 2017 to February, 2019. 61 patients, aged >18 years with the diagnosis of PsA for ≥3 months were randomized into two groups. 29 patients (Tofacitinib 5mg BD) and 32 patients (MTX from 15 mg/week to 25 mg/week over 1 month) were enrolled and followed-up at the end of 1, 3 and 6 months. Primary endpoint was ACR 20 response at the end of 3 months. Patients who achieved treatment target on the basis of DAPSA score at the end of 3 months were allowed to continue previuos treatment and assessed for safety and efficacy till 6 months. Patients not achieving treatment target in Tofacitinib group were put on Tofacitinib 10 mg BD and in MTX group were put on Tofacitinib 5 mg BD. These patients were followed-up for safety and efficacy at the end of 6 months. Secondary outcome measures were EULAR response, 66/68 joints SJC/TJC, VAS for pain, ESR, CRP, DAPSA, DAS28, PASI, PASI 75 response, MASES and HAQ-DI. Safety assessment was done on the basis of clinical history, examination and laboratory findings at each follow-up. Ethical clearance was obtained from IRB, BSMMU at the beginning. Statistical analysis was done using chi-square test, Fisher's exact test, paired sample t-test and independent sample t-test. Missing data were dealt with intention to treat (ITT) analysis.
- Conditions
- Psoriatic Arthritis
- Being tested
- Group A- Tofacitinib, Group B- Methotrexate
- Keywords
- PsA
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A- TofacitinibDrug
Also called Tofacitinib
Group A patients will receive Tofacitinib 5mg BD. Patients will be followed up at 1, 3 and 6 months. Patients with inadequate response to Tofacitinib 5 mg BD at the end of 3 months will be put on Tofacitinib 10 mg BD. Primary endpoint for efficacy will be determined by ACR 20 response.
Group B- MethotrexateDrug
Also called Methotrexate
Group B patients will receive Methotrexate in increasing dose weekly with maximum dose up to 25 mg/week. Patients will be followed up at 1, 3 and 6 months. Patients with inadequate response to highest dose of MTX at the end of 3 months will be put on Tofacitinib 5 mg BD. Primary endpoint for efficacy will be determined by ACR 20 response.
| Study group | Role | What they receive |
|---|---|---|
| Group A- Tofacitinib | Experimental | Tofacitinib 5mg twice daily orally. Patients with inadequate response to Tofacitinib 5 mg BD at the end of 3 months will be put on Tofacitinib 10 mg BD. Receives: Drug: Group A- Tofacitinib |
| Group B- Methotrexate | Placebo comparator | Methotrexate in increasing dose starting from 15 mg weekly to a maximum dose of 25 mg weekly from the end of 1st month. Patients with inadequate response to highest dose of MTX at the end of 3 months will be put on Tofacitinib 5 mg BD. Receives: Drug: Group B- Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
American college of Rheumatology 20 (ACR 20) response
This response criteria is achieved if there is 20% improvement in tender or swollen joint counts along with 20% improvement in three of the following five parameters:
- Erythrocyte sedimentation rate in mm in 1st hour
- Patient assessment in numerical scale of 10 (range: 0-10)
- Physician assessment in numerical scale of 10 (range: 0-10)
- Visual analog pain scale (range: 0-10)
- Disability/functional questionnaire with maximum score of 3 (range: 0-3)
Measured: 3 months
Secondary outcomes (10)
Disease activity score-28 joint-ESR score (DAS28-ESR)
Disease activity score for assessment of disease activity of rheumatoid arthritis. It is calculated using the following parameters:
- Tender joint count- 28 joints
- Swollen joint count- 28 joints
- Patient global assessment (range 1-10)
- Erythrocyte sedimentation rate in mm in 1st hour Greater score means poor prognosis.A score of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission.
Measured: 1, 3 and 6 months
Disease activity index for psoriatic Arthritis (DAPSA)
The DAPSA score consists of five variables: tender and swollen joints (TJC68, SJC66), patient global assessment and patient pain assessment (each on a 10-cm visual analogue scale [VAS]), and CRP. The addition of these variables is the result.
Disease Activity: 0-4 Remission, 5-14 low, 15-28 moderate, >28 high Disease Activity
Measured: 1, 3 and 6 months
Psoriasis Area and Severity Index (PASI)
PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease).
The body is divided into four sections (head (H) (10% of a person's skin); arms (A) (20%); trunk (T) (30%); legs (L) (40%)). Each of these areas is scored by itself, and then the four scores are combined into the final PASI. For each section, the percent of area of skin involved, is estimated and then transformed into a grade from 0 to 6:
- 0% of involved area
- < 10% of involved area
- 10-29% of involved area
- 30-49% of involved area
- 50-69% of involved area
- 70-89% of involved area
- 90-100% of involved area Within each area, the severity is estimated by three clinical signs: erythema, induration and desquamation.
Measured: 1, 3 and 6 months
Maastricht Ankylosing Spondylitis Enthesitis Score
The Maastricht Ankylosing Spondylitis Enthesitis Score uses 13 most specific and sensitive sites. These include the bilateral first and seventh costochondral joints, the anterior and posterior superior iliac spines, the iliac crests, the fifth lumbar spinous process, and the proximal insertion of Achilles tendon.
Total score-13 Range: 0-13 Greater score implies greeater entheses involvement, and thus greater disease activity.
Measured: 1, 3 and 6 months
Health Assessment Questionnaire- Disability Index
An assessment tool for chronic diseases. A questionnaire where a person indicates the amount of difficulty they have with: dressing and grooming, arising, eating, walking, hygiene, reaching, gripping and performing common daily activities.
Total score- 3 Range- 0-3 Higher scores indicates higher disability.
Measured: 1, 3 and 6 months
EULAR response
EULAR response according to predefined changes in DAS28-ESR scores
Measured: 3 months
66/68 joints SJC/TJC
SJC- swollen joint count and TJC- tender joint count
Measured: 1, 3 and 6 months
ESR
Erythrocyte sedimentation rate
Measured: 1, 3 and 6 months
CRP
C-reactive protein
Measured: 1, 3 and 6 months
PASI75 response
75% improvement in PASI score
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start15 Sep 2017
- Primary completion28 Sep 2019
- Study completion28 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label randomized trial
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Globe Pharmaceuticals Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Prayush Sharma, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Prayush Sharma, MD, Principal investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736161
- Sponsor's protocol ID
- PsOLSET-BD
- Acronym
- PsOLSET-BD
- Status last verified
- Oct 2019
- First submitted
- 2 Nov 2018
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jandus C, Bioley G, Rivals JP, Dudler J, Speiser D, Romero P. Increased numbers of circulating polyfunctional Th17 memory cells in patients with seronegative spondylarthritides. Arthritis Rheum. 2008 Aug;58(8):2307-17. doi: 10.1002/art.23655.
PubMed 18668556Ghoreschi K, Jesson MI, Li X, Lee JL, Ghosh S, Alsup JW, Warner JD, Tanaka M, Steward-Tharp SM, Gadina M, Thomas CJ, Minnerly JC, Storer CE, LaBranche TP, Radi ZA, Dowty ME, Head RD, Meyer DM, Kishore N, O'Shea JJ. Modulation of innate and adaptive immune responses by tofacitinib (CP-690,550). J Immunol. 2011 Apr 1;186(7):4234-43. doi: 10.4049/jimmunol.1003668. Epub 2011 Mar 7.
PubMed 21383241Moll JM, Wright V. Familial occurrence of psoriatic arthritis. Ann Rheum Dis. 1973 May;32(3):181-201. doi: 10.1136/ard.32.3.181. No abstract available.
PubMed 4715537Ritchlin C, Haas-Smith SA, Hicks D, Cappuccio J, Osterland CK, Looney RJ. Patterns of cytokine production in psoriatic synovium. J Rheumatol. 1998 Aug;25(8):1544-52.
PubMed 9712099Rosengren S, Corr M, Firestein GS, Boyle DL. The JAK inhibitor CP-690,550 (tofacitinib) inhibits TNF-induced chemokine expression in fibroblast-like synoviocytes: autocrine role of type I interferon. Ann Rheum Dis. 2012 Mar;71(3):440-7. doi: 10.1136/ard.2011.150284. Epub 2011 Nov 25.
PubMed 22121136Taylor W, Gladman D, Helliwell P, Marchesoni A, Mease P, Mielants H; CASPAR Study Group. Classification criteria for psoriatic arthritis: development of new criteria from a large international study. Arthritis Rheum. 2006 Aug;54(8):2665-73. doi: 10.1002/art.21972.
PubMed 16871531Langley RG, Krueger GG, Griffiths CE. Psoriasis: epidemiology, clinical features, and quality of life. Ann Rheum Dis. 2005 Mar;64 Suppl 2(Suppl 2):ii18-23; discussion ii24-5. doi: 10.1136/ard.2004.033217.
PubMed 15708928Gladman DD, Antoni C, Mease P, Clegg DO, Nash P. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005 Mar;64 Suppl 2(Suppl 2):ii14-7. doi: 10.1136/ard.2004.032482.
PubMed 15708927Sherlock JP, Joyce-Shaikh B, Turner SP, Chao CC, Sathe M, Grein J, Gorman DM, Bowman EP, McClanahan TK, Yearley JH, Eberl G, Buckley CD, Kastelein RA, Pierce RH, Laface DM, Cua DJ. IL-23 induces spondyloarthropathy by acting on ROR-gammat+ CD3+CD4-CD8- entheseal resident T cells. Nat Med. 2012 Jul 1;18(7):1069-76. doi: 10.1038/nm.2817.
PubMed 22772566Partsch G, Steiner G, Leeb BF, Dunky A, Broll H, Smolen JS. Highly increased levels of tumor necrosis factor-alpha and other proinflammatory cytokines in psoriatic arthritis synovial fluid. J Rheumatol. 1997 Mar;24(3):518-23.
PubMed 9058659Gossec L, Smolen JS, Ramiro S, de Wit M, Cutolo M, Dougados M, Emery P, Landewe R, Oliver S, Aletaha D, Betteridge N, Braun J, Burmester G, Canete JD, Damjanov N, FitzGerald O, Haglund E, Helliwell P, Kvien TK, Lories R, Luger T, Maccarone M, Marzo-Ortega H, McGonagle D, McInnes IB, Olivieri I, Pavelka K, Schett G, Sieper J, van den Bosch F, Veale DJ, Wollenhaupt J, Zink A, van der Heijde D. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis. 2016 Mar;75(3):499-510. doi: 10.1136/annrheumdis-2015-208337. Epub 2015 Dec 7.
PubMed 26644232Maeshima K, Yamaoka K, Kubo S, Nakano K, Iwata S, Saito K, Ohishi M, Miyahara H, Tanaka S, Ishii K, Yoshimatsu H, Tanaka Y. The JAK inhibitor tofacitinib regulates synovitis through inhibition of interferon-gamma and interleukin-17 production by human CD4+ T cells. Arthritis Rheum. 2012 Jun;64(6):1790-8. doi: 10.1002/art.34329. Epub 2011 Dec 6.
PubMed 22147632Kane D, Jensen LE, Grehan S, Whitehead AS, Bresnihan B, Fitzgerald O. Quantitation of metalloproteinase gene expression in rheumatoid and psoriatic arthritis synovial tissue distal and proximal to the cartilage-pannus junction. J Rheumatol. 2004 Jul;31(7):1274-80.
PubMed 15229943Smolen JS, Aletaha D, Gruben D, Zwillich SH, Krishnaswami S, Mebus C. Brief Report: Remission Rates With Tofacitinib Treatment in Rheumatoid Arthritis: A Comparison of Various Remission Criteria. Arthritis Rheumatol. 2017 Apr;69(4):728-734. doi: 10.1002/art.39996. Epub 2017 Mar 8.
PubMed 27907269Helliwell P, Coates LC, FitzGerald O, Nash P, Soriano ER, Elaine Husni M, Hsu MA, Kanik KS, Hendrikx T, Wu J, Kudlacz E. Disease-specific composite measures for psoriatic arthritis are highly responsive to a Janus kinase inhibitor treatment that targets multiple domains of disease. Arthritis Res Ther. 2018 Oct 29;20(1):242. doi: 10.1186/s13075-018-1739-0.
PubMed 30373651
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Tofacitinib vs Methotrexate in the Treatment of Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT03736161
- Acronym / sponsor ID
- PsOLSET-BD / PsOLSET-BD
- Conditions
- Psoriatic Arthritis
- Keywords
- PsA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Globe Pharmaceuticals LimitedUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 28 Sep 2019 (actual)
- Study completion
- 28 Sep 2019 (actual)
- First posted
- 9 Nov 2018 (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.
Title Safety and Efficacy of Tofacitinib vs Methotrexate in the treatment of Psoriatic Arthritis- An Open Label Randomized single center study Psoriatic arthritis is defined as an inflammatory arthropathy associated with skin psoriasis and usually negative for rheumatoid factor. Till date, many NSAIDs, corticosteroids, DMARDs have been used, but the safety and efficacy issues demands more researches. The prevalence of PsA worldwide is about 1%-2% and among patients with psoriasis ranges from 7% to 42%. The pathogenesis of PsA involves many cytokines. Tofacitinib is an oral Janus Kinase (JAK) inhibitor with immunomodulatory and anti-inflammatory mechanism. It binds to JAK and prevents the activation of the JAK-signal transducers and activators of transcription (STAT) signaling pathway which ultimately decreases the production of pro-inflammatory cytokines, and prevents both inflammatory response and the inflammation-induced damage. It has shown better efficacy in many diseases like Rheumatoid Arthritis, Axial spondyloarthropathies, Psoriasis, Psoriatic Arthritis, Alopecia areata, dry eye disease.
This prospective, open label, randomized study will be conducted in inpatient and outpatient departments of Rheumatology, BSMMU, Dhaka, Bangladesh in 110 adult volunteers (>18 years) of both genders diagnosed as psoriatic arthritis. Patients will be divided equally into two groups, Group A will be put on Tofacitinib 5 mg twice daily and Group B will be put on Methotrexate weekly in increasing dose with maximum dose of 25 mg weekly. Groups will be divided on the basis of randomization by random number table. Patients with inadequate response to highest dose of MTX or Tofacitinib 5 mg BD at the end of 3 months will be put on Tofacitinib 5 mg BD or Tofacitinib 10 mg BD respectively. The patients not eligible for therapy will not be included in the study. Patients will be followed up at 1, 3 and 6 months. Baseline characteristics will be monitored and recorded at 3 and 6 months.
The clinical information of the study subjects will be recorded in a structured history, clinical examination and questionnaire. All subjects will be enrolled after having informed written consent. The participants will enjoy every right to participate or withdraw from the study at any point of time. Response to Tofacitinib will be expressed in mean, standard deviation and percentage. Ethical clearance will be taken from the Institutional Review Board (IRB) of BSMMU.
Detailed description
Background:
Methotrexate, an anti-folate drug, is a widely accepted and commonly used DMARD for the treatment of PsA. Tofacitinib is a JAK inhibitor, and relatively new drug for this condition.
Aims:
To assess and compare safety and efficacy of Tofacitinib and Methotrexate in the treatment of PsA.
Methodology:
This open label, randomized, prospective study was conducted in Department of Rheumatology, BSMMU, Dhaka for 1½ years from September, 2017 to February, 2019. 61 patients, aged >18 years with the diagnosis of PsA for ≥3 months were randomized into two groups. 29 patients (Tofacitinib 5mg BD) and 32 patients (MTX from 15 mg/week to 25 mg/week over 1 month) were enrolled and followed-up at the end of 1, 3 and 6 months. Primary endpoint was ACR 20 response at the end of 3 months. Patients who achieved treatment target on the basis of DAPSA score at the end of 3 months were allowed to continue previuos treatment and assessed for safety and efficacy till 6 months. Patients not achieving treatment target in Tofacitinib group were put on Tofacitinib 10 mg BD and in MTX group were put on Tofacitinib 5 mg BD. These patients were followed-up for safety and efficacy at the end of 6 months. Secondary outcome measures were EULAR response, 66/68 joints SJC/TJC, VAS for pain, ESR, CRP, DAPSA, DAS28, PASI, PASI 75 response, MASES and HAQ-DI. Safety assessment was done on the basis of clinical history, examination and laboratory findings at each follow-up. Ethical clearance was obtained from IRB, BSMMU at the beginning. Statistical analysis was done using chi-square test, Fisher's exact test, paired sample t-test and independent sample t-test. Missing data were dealt with intention to treat (ITT) analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label randomized trial
| Arm | Type | Receives |
|---|---|---|
| Group A- Tofacitinib | Experimental | Drug: Group A- TofacitinibTofacitinib 5mg twice daily orally. Patients with inadequate response to Tofacitinib 5 mg BD at the end of 3 months will be put on Tofacitinib 10 mg BD. |
| Group B- Methotrexate | Placebo comparator | Drug: Group B- MethotrexateMethotrexate in increasing dose starting from 15 mg weekly to a maximum dose of 25 mg weekly from the end of 1st month. Patients with inadequate response to highest dose of MTX at the end of 3 months will be put on Tofacitinib 5 mg BD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients more than 18 years
- Psoriatic arthritis > 3 months with peripheral involvement diagnosed on the basis of CASPAR criteria
- Unresponsive to more than 2 NSAIDs at maximum recommended doses for more than 4 weeks, i.e 2 weeks for each NASID
- 5. Patients with active disease 6. PsA with or without extra-articular features like enthesitis, dactylitis and nail changes
Key exclusion criteria (12 listed)
- Systemic infections requiring hospital admission during the past 6 months
- A history of active infectious disorders (including active or latent tuberculosis), and/or a history of chronic or recurrent serious infective diseases, opportunistic infections
- Hemoglobin (Hb) < 9 g/dl
- White blood cell count < 3000, Neutrophil count < 1000, Platelet count < 100000
- Live vaccines within 3 months prior to the first dose
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 |
|---|---|---|
| Group A- TofacitinibAlso: TofacitinibGroup A patients will receive Tofacitinib 5mg BD. Patients will be followed up at 1, 3 and 6 months. Patients with inadequate response to Tofacitinib 5 mg BD at the end of 3 months will be put on Tofacitinib 10 mg BD. Primary endpoint for efficacy will be determined by ACR 20 response. | Drug | Group A- Tofacitinib |
| Group B- MethotrexateAlso: MethotrexateGroup B patients will receive Methotrexate in increasing dose weekly with maximum dose up to 25 mg/week. Patients will be followed up at 1, 3 and 6 months. Patients with inadequate response to highest dose of MTX at the end of 3 months will be put on Tofacitinib 5 mg BD. Primary endpoint for efficacy will be determined by ACR 20 response. | Drug | Group B- Methotrexate |
Primary outcome
American college of Rheumatology 20 (ACR 20) response
Time frame: 3 months
This response criteria is achieved if there is 20% improvement in tender or swollen joint counts along with 20% improvement in three of the following five parameters: 1. Erythrocyte sedimentation rate in mm in 1st hour 2. Patient assessment in numerical scale of 10 (range: 0-10) 3. Physician assessment in numerical scale of 10 (range: 0-10) 4. Visual analog pain scale (range: 0-10) 5. Disability/functional questionnaire with maximum score of 3 (range: 0-3)
10 secondary outcomes
Disease activity score-28 joint-ESR score (DAS28-ESR)
Time frame: 1, 3 and 6 months
Disease activity index for psoriatic Arthritis (DAPSA)
Time frame: 1, 3 and 6 months
Psoriasis Area and Severity Index (PASI)
Time frame: 1, 3 and 6 months
Maastricht Ankylosing Spondylitis Enthesitis Score
Time frame: 1, 3 and 6 months
Health Assessment Questionnaire- Disability Index
Time frame: 1, 3 and 6 months
EULAR response
Time frame: 3 months
66/68 joints SJC/TJC
Time frame: 1, 3 and 6 months
ESR
Time frame: 1, 3 and 6 months
CRP
Time frame: 1, 3 and 6 months
PASI75 response
Time frame: 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Background: PubMed 18668556Jandus C, Bioley G, Rivals JP, Dudler J, Speiser D, Romero P. Increased numbers of circulating polyfunctional Th17 memory cells in patients with seronegative spondylarthritides. Arthritis Rheum. 2008 Aug;58(8):2307-17. doi: 10.1002/art.23655.
- Background: PubMed 21383241Ghoreschi K, Jesson MI, Li X, Lee JL, Ghosh S, Alsup JW, Warner JD, Tanaka M, Steward-Tharp SM, Gadina M, Thomas CJ, Minnerly JC, Storer CE, LaBranche TP, Radi ZA, Dowty ME, Head RD, Meyer DM, Kishore N, O'Shea JJ. Modulation of innate and adaptive immune responses by tofacitinib (CP-690,550). J Immunol. 2011 Apr 1;186(7):4234-43. doi: 10.4049/jimmunol.1003668. Epub 2011 Mar 7.
- Background: PubMed 4715537Moll JM, Wright V. Familial occurrence of psoriatic arthritis. Ann Rheum Dis. 1973 May;32(3):181-201. doi: 10.1136/ard.32.3.181. No abstract available.
- Background: PubMed 9712099Ritchlin C, Haas-Smith SA, Hicks D, Cappuccio J, Osterland CK, Looney RJ. Patterns of cytokine production in psoriatic synovium. J Rheumatol. 1998 Aug;25(8):1544-52.
- Background: PubMed 22121136Rosengren S, Corr M, Firestein GS, Boyle DL. The JAK inhibitor CP-690,550 (tofacitinib) inhibits TNF-induced chemokine expression in fibroblast-like synoviocytes: autocrine role of type I interferon. Ann Rheum Dis. 2012 Mar;71(3):440-7. doi: 10.1136/ard.2011.150284. Epub 2011 Nov 25.
- Background: PubMed 16871531Taylor W, Gladman D, Helliwell P, Marchesoni A, Mease P, Mielants H; CASPAR Study Group. Classification criteria for psoriatic arthritis: development of new criteria from a large international study. Arthritis Rheum. 2006 Aug;54(8):2665-73. doi: 10.1002/art.21972.
- Background: PubMed 15708928Langley RG, Krueger GG, Griffiths CE. Psoriasis: epidemiology, clinical features, and quality of life. Ann Rheum Dis. 2005 Mar;64 Suppl 2(Suppl 2):ii18-23; discussion ii24-5. doi: 10.1136/ard.2004.033217.
- Background: PubMed 15708927Gladman DD, Antoni C, Mease P, Clegg DO, Nash P. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005 Mar;64 Suppl 2(Suppl 2):ii14-7. doi: 10.1136/ard.2004.032482.
- Background: PubMed 22772566Sherlock JP, Joyce-Shaikh B, Turner SP, Chao CC, Sathe M, Grein J, Gorman DM, Bowman EP, McClanahan TK, Yearley JH, Eberl G, Buckley CD, Kastelein RA, Pierce RH, Laface DM, Cua DJ. IL-23 induces spondyloarthropathy by acting on ROR-gammat+ CD3+CD4-CD8- entheseal resident T cells. Nat Med. 2012 Jul 1;18(7):1069-76. doi: 10.1038/nm.2817.
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- Safety, efficacy and tolerability of oral tofacitinib in Japanese patients with psoriasis and psoriatic arthritisLink provided by the sponsor.
- Modulation of innate and adaptive immune by TofacitinibLink provided by the sponsor.
- EULAr 2015 recommendations for the treatment of Psoriatic ArthritisLink provided by the sponsor.
- Pfizer's poster and oral presentation at ACR conferenceLink provided by the sponsor.
- 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.
Prayush Sharma, MD principal investigator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Group A- Tofacitinib and Group B- Methotrexate in people with Psoriatic Arthritis, run by Globe Pharmaceuticals Limited at 1 site in Bangladesh.
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 4 inclusion and 12 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: finished, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American college of Rheumatology 20 (ACR 20) response (time frame: 3 months). 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 NCT03736161, which also lists 34 linked publications.
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 21 Oct 2019; AzTrials last refreshed its copy on 8 Nov 2026.