Tofacitinib in the Treatment of Refractory Axial Spondyloarthritis Patients: A Dose Escalation Study

NCT06310057 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 4139
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess the efficacy of tofacitinib in refractory axial spodyloarthritis (ax-SpA) with dose escalation from 10mg to 15mg. Patients will start on 10mg and then divided into 2 groups (10 and 15) at 3rd month according to major improvement criteria. The main question\[s\] it aims to answer are:

• Efficacy and safety of tofacitinib in different doses
• If escalation of tofacitinib is justified if clinical criteria is not fulfilled at 10mg

Conditions

Axial Spondyloarthritis

Outcome Measures

Primary Outcomes (1)

• To assess the ASDAS CRP major improvement criteria in refractory ax-SpA patients with dose escalation from 10mg to 15mg

  To assess the ASDAS CRP major improvement criteria in refractory ax-SpA patients with dose escalation from 10mg to 15mg

  6 months

Secondary Outcomes (1)

• Clinicodemographic characteristics of Ax-SpA, ASDAS CRP outcome rates, quality of life, adverse effects

  6 months

Study Arms (2)

Tofacitinib 10mg

EXPERIMENTAL

All patient that fulfill the inclusion ans exclusion criteria will start at 10mg tofacitinib.

Drug: Tofacitinib

Tofacitinib 15 mg

EXPERIMENTAL

At 3rd month, patients that do not fulfill the ASDAS major improvement criteria will get 15mg tofacitinib.

Drug: Tofacitinib

Interventions

Tofacitinib DRUG

Tofacitinib (JAKi) is a targeted therapy option for patients with refractory ax-SpA.

Tofacitinib 10mg; Tofacitinib 15 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Patient fulfill the ASAS classification criteria for ax-SpA
• Patient fulfill the definition of refractory axial ax-SpA
• Patients with ASDAS-CRP\>2.1

You may not qualify if:

• Patient currently taking or had prior treatment with bDMARD or tsDMARD (including JAK inhibitor)
• Patient with any active or history of any chronic or recurrent or serious or opportunistic infection/sepsis (including tuberculosis)
• Hemoglobin (Hb) \< 9 g/dl
• White blood cell count \< 4000, Neutrophil count \< 1000, Platelet count \< 100000/mm3
• Live vaccines within 3 months prior to the first dose
• 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
• Evidence or history of malignancy
• New York Heart Association Class III and IV congestive heart failure
• Any lymphoproliferative disorder, history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead
• Incepta Pharmaceuticals Ltd: collaborator

Study Sites (1)

Bangabandhu Sheikh Mujib Medical University

Dhaka, 1000, Bangladesh

Location

MeSH Terms

Conditions

Axial Spondyloarthritis

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Resident

Model Details: Dose escalation study, all the patients will recieve 10mg tofacitinib at the beginning. Then at 3rd month, one group will continue at 10mg, if they fulfill the ASDAS major improvement criteria and other group will escalate to 15mg.

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 13, 2024
• Study Start: January 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

BA (1)