Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06310057
Other study ID # 4139
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 1, 2022
Est. completion date March 1, 2024

Study information

Verified date March 2024
Source Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

Axial spondyloarthritis (ax-SpA) is a major cause of chronic low back pain in the young. It causes significant disability and impairs quality of life. Management of (ax-SpA) includes physical therapy along with NSAIDs, followed by TNFi or IL-17i or JAKi in refractory ax-SpA. In Bangladesh, TNFi and IL-17i are expensive, whereas Tofacitinib (JAKi) is affordable and widely used in Bangladesh. However, recent study shows that a significant number of patients, 39.4% do not meet criteria for ASDAS CRP clinically important criteria and only 26% meets the criteria for ASDAS major improvement to tofacitinib 10mg daily. 102 patients of refractory ax-SpA meeting the enrollment criteria will be taken and put on 10mg tofacitinib. Those who fail to attain ASDAS CRP major improvement criteria at 12 weeks will be put on 15mg tofacitinib and both the groups will be compared at week 24 in a dose escalation study. No studies have been done on 15mg tofacitinib for ax-SpA, such a study will provide us ground for escalation of tofacitinib. Regarding safety issues, FDA has warned against the use of 20mg tofacitinib but not for 15mg. Baseline characteristics and variables will be recorded at initiation of therapy, 4th, 12th and 24th week. The study will take place in Rheumatology outdoor, BSMMU and Modern One Stop Arthritis Care and Research Centre, Dhaka from July 2022- April 2024. Patient's socio-demographic and clinical data will be taken in a semi-structured questionnaire. At every follow up detailed history, thorough physical examination and investigations will be done to evaluate the efficacy and adverse effects. Patients will be assessed for response, ASDAS-CRP, ASDAS-ESR, ASAS-20, BASFI, BASDAI, BASMI, ASQoL, SF-36, MASES and VAS will be noted. CBC, CRP, S. creatinine and S. ALT will be done during follow up.


Recruitment information / eligibility

Status Completed
Enrollment 92
Est. completion date March 1, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age =18 years 2. Patient fulfill the ASAS classification criteria for ax-SpA 3. Patient fulfill the definition of refractory axial ax-SpA 4. Patients with ASDAS-CRP>2.1 Exclusion Criteria: 1. Patient currently taking or had prior treatment with bDMARD or tsDMARD (including JAK inhibitor) 2. Patient with any active or history of any chronic or recurrent or serious or opportunistic infection/sepsis (including tuberculosis) 3. Hemoglobin (Hb) < 9 g/dl 4. White blood cell count < 4000, Neutrophil count < 1000, Platelet count < 100000/mm3 5. Live vaccines within 3 months prior to the first dose 6. GFR less than 50 mL/min 7. Alanine aminotransaminase (ALT) more than 2 times of ULN 8. Pregnant or breast feeding females of child-bearing potential not using highly effective contraception 9. Evidence or history of malignancy 10. New York Heart Association Class III and IV congestive heart failure 11. Any lymphoproliferative disorder, history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Bangladesh Bangabandhu Sheikh Mujib Medical University Dhaka

Sponsors (2)

Lead Sponsor Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh Incepta Pharmaceuticals Ltd

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Clinicodemographic characteristics of Ax-SpA, ASDAS CRP outcome rates, quality of life, adverse effects To compare the clinicodemographic characteristics of refractory ax-SpA patients with and without ASDAS CRP major improvement outcome
To determine the ASDAS CRP outcome rates with 10 mg and 15mg tofacitinib
To evaluate the change in quality of life with the outcome of ASDAS CRP
To evaluate the adverse effects of 10 mg and 15 mg tofacitinib
6 months
See also
  Status Clinical Trial Phase
Completed NCT05031767 - Remote Monitoring of Axial Spondyloarthritis N/A
Completed NCT05162937 - to Evaluate the Preliminary Efficacy and Safety of GR1501 Injection in Patients With Active Axial Spondyloarthritis Phase 2
Completed NCT03622658 - Efficacy and Safety of Namilumab for Moderate-to-severe Axial Spondyloarthritis Phase 2
Completed NCT03248518 - Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases N/A
Terminated NCT02437162 - A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNFα Naive Participants With Active Radiographic Axial Spondyloarthritis Phase 3
Enrolling by invitation NCT06072859 - The Impact of Simulated Forest Immersion Therapy on Pain and Anxiety in Patients Axial Spondyloarthritis (axSpA) N/A
Completed NCT02552212 - Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS Phase 3
Active, not recruiting NCT02687620 - Does Immunogenicity Have an Influence on the Efficacy of Anti-TNF Therapy in Patients With AS: An Inception Cohort Study
Active, not recruiting NCT01944163 - The IMPACT of a Referral Model for Axial Spondyloarthritis in Young Patients With Chronic Low Back Pain N/A
Completed NCT00844805 - Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1) Phase 3
Terminated NCT02897115 - A Study Treating Participants With Early Axial Spondyloarthritis (axSpA) Taking an Intense Treatment Approach Versus Routine Treatment Phase 4
Completed NCT05019547 - The Turkish Version of the Inflammatory Arthritis Facilitators and Barriers to Physical Activity
Recruiting NCT03738956 - Safety and Efficacy of Tofacitinib in the Treatment of NSAID Refractory Axial Spondyloarthritis:A Clinical Trial Phase 2/Phase 3
Completed NCT04679649 - Physiotherapy of Axial Spondyloarthritis N/A
Enrolling by invitation NCT02962479 - Is the Human Microbiome Altered in Patients With Axial Spondyloarthritis? N/A
Completed NCT04485078 - Investigation of Central Sensitization Frequency and Related Factors in Axial Spondyloarthritis Patients
Recruiting NCT05812157 - Optimizing Anti-IL17 Antibody Therapy by Associating Fiber Supplementation to Correct Treatment-aggravated Gut Dysbiosis in Axial Spondyloarthritis - RESPOND-IL17 N/A
Completed NCT03039088 - PREDICT-SpA - French Epidemiological Study of the Evaluation of the Impact of Fibromyalgia in the TNF Alpha Treatment Effect in Axial Spondyloarthritis in Both Anti-TNF naïve and - Experienced Patients
Completed NCT04368494 - Exercise Therapy in Patients With Axial Spondyloarthritis N/A
Completed NCT03270501 - Efficacy of Golimumab in Early Axial Spondyloarthritis in Relation to Gut Inflammation Phase 3