Rheumatoid Arthritis (RA)Phase 4NCT07636057
Comparison of Effectiveness and Safety of Tofacitinib Versus Upadacitinib as Add-on to Methotrexate in Rheumatoid Arthritis
A Phase 4 study testing JAK inhibitor(tofacitinib/upadacitinib) as advised by the rheumatologist as add on to 25 mg methotrexate in people with Rheumatoid Arthritis (RA), run by Sheikh Zayed Federal Postgraduate Medical Institute.
Trial summary
The goal of this interventional study is to learn, whether Tofacitinib or upadacitinib is more effective in treating the patients of Rheumatoid Arthritis. It will also learn about the safety of these two agents. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- JAK inhibitor(tofacitinib/upadacitinib) as advised by the rheumatologist as add on to 25 mg methotrexate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 5 Jul 2026to 10 May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Adult patients aged ≥18 years, regardless of gender
Who cannot join
- • Other autoimmune rheumatic disorders (SLE, psoriatic arthritis, AS, etc.)
- Administration of any biologic DMARD in the previous three months
- History of a serious infection (e.g., active tuberculosis or sepsis)
- Previous or existing history of recurrent infections or immunosuppressive status
- History of any malignancy in the last five years.
- Current chemotherapy, radiotherapy or intake of any genotoxic drug
Show all 12Show fewer
- Severe liver impairment (e.g., ALT/AST >3× ULN)
- Severe renal impairment (e.g., estimated GFR <30 mL/min)
- Severe Haematological Abnormalities: Hb <8 g/dL, TLC <3,000 /mm³, Platelets <100,000 /mm³
- Past or present deep vein thrombosis or pulmonary embolism
- Pregnant or lactating women
- Women of reproductive age who are not practicing adequate contraception measures
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Dr Sadia Maqsood Awan Assistant Professor Pharmacology FPGMI Lahore, MBBS, M.phil,MHPE contact
Dr Mudassra yaseen HOD pharmacology FPGMI, Lahore, MBBS, M.phil, CMT, PhD contact
About this study
Official title: Effectiveness and Safety of Tofacitinib Versus Upadacitinib as Add-on to Methotrexate in Rheumatoid Arthritis; Comparative Clinical Study
The goal of this interventional study is to learn, whether Tofacitinib or upadacitinib is more effective in treating the patients of Rheumatoid Arthritis. It will also learn about the safety of these two agents. The main questions it aims to answer are:
- Which JAK inhibitor (Tofacitinib or Upadacitinib) is more effective to improve the disease activity of Rheumatoid arthritis in Pakistani population?
- What is the Disease Activity scores, ESR, CRP, RA factor level of patients?
- What are the side effects of both drugs, during the study time?
Read more
Participants:
- Of Group A will be taking 5mg Tofacitinib oral daily for 6 months along with 25mg of once weekly dose of oral Methotrexate, whereas of Group B will be taking 15mg Upadacitinib oral daily for 6 months along with 25mg of once weekly dose of oral methotrexate.
- Will Visit the clinic once at 3 months and then 6 months for checkups and tests
- Will Keep a diary of any infection, treatment taken, duration of infection
- Will inform the researcher about any unusual side effect during the study
Read the detailed description
This study will be conducted in the Department of Pharmacology in collaboration with Rheumatology Department of Shaikh Zayed Medical Complex, Lahore.
The study population will consist of adult patients with diagnosis of RA on the basis of EULAR 2010 Classification Criteria: Moderate to severe disease activity indicated by DAS28 >3.2 and those with Inadequate response to methotrexate (MTX) characterized by Persistent active disease on ≥12 weeks of MTX treatment.
Sample size was estimated considering the following clinically significant variables: infection rate, thrombotic events, and cessation of treatment as a result of remission according to scientific publications. The maximum sample size was estimated among these methods in order to have adequate power.
If infection rate was considered as a key safety parameter, and taking into account the event rates of 0.7 and 1.2 per 100 patient-years for Tofacitinib and Upadacitinib, respectively22, the sample size would be 116 patients (58 per group) at 95% confidence interval and 80% power. In the case of thrombotic events with an assumed event rate of 0.2 and 0.4 per 100 patient-years23, the required sample size would be 100 patients (50 per group) at 95% confidence interval and 90% power.
Adult patients aged ≥18 years, regardless of gender will be included in the study. Whereas the following patients will not be included:
- Other autoimmune rheumatic disorders (SLE, psoriatic arthritis, AS, etc.)
- Administration of any biologic DMARD in the previous three months
- History of a serious infection (e.g., active tuberculosis or sepsis)
- Previous or existing history of recurrent infections or immunosuppressive status
- History of any malignancy in the last five years.
- Current chemotherapy, radiotherapy or intake of any genotoxic drug
- Severe liver impairment (e.g., ALT/AST >3× ULN)
- Severe renal impairment (e.g., estimated GFR <30 mL/min)
- Severe Haematological Abnormalities: Hb <8 g/dL, TLC <3,000 /mm³, Platelets <100,000 /mm³
- Past or present deep vein thrombosis or pulmonary embolism
- Pregnant or lactating women
- Women of reproductive age who are not practicing adequate contraception measures
Data collection procedure:
After the Evaluation by rheumatologist and prescribing the tofacitinib or Upadacitinib, an informed consent will be taken from the patient. Baseline investigations and history will be taken and added to the data collection sheet (Attached at the end). Patients will be followed vigilantly and then the clinical evaluation \& biochemical investigations will be recorded at 3 months and 6 months.
Statistical Analysis:
All analyses will be conducted according to the ITT principle. A per protocol analysis will also be performed as sensitivity analysis. Two-sided p ≤ 0.05 will be considered statistically significant.
Continuous variable will be presented as mean±SD/median (IQR) and categorical variables will be presented as frequency (%).
Comparison of proportion between groups will be performed using the Chi-square/Fisher's exact test and effect sizes will be calculated as Risk difference, relative risk (RR) with 95% confidence interval.
Change in DAS28 will be compared by using Independent sample t-test/Mann Whitney-U test. Repeated measures analysis (mixed model/ANOVA) will be used to see the groups and time effect simultaneously. ACR responses will be analyzed by using Chi-square test Comparison of incidence rate between groups will be performed using Chi-square/Fisher's exact test and rates will be presented as proportion and/or incidences per 100 patient years.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- JAK inhibitor(tofacitinib/upadacitinib) as advised by the rheumatologist as add on to 25 mg methotrexate
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JAK inhibitor(tofacitinib/upadacitinib) as advised by the rheumatologist as add on to 25 mg methotrexateDrug
There is no comparative study of tofacitinib with upadacitinib in Pakistan, as upadacitinib is recently been available here. There is no study yet in pakistan to compare the effectiveness and safety of these two JAK inhibitors in Pakistani population.
| Study group | Role | What they receive |
|---|---|---|
| Tofacitinib | Experimental | 5mg tofacitinib BD(oral) daily + 25mg Methotrexate oral once in a week Receives: Drug: JAK inhibitor(tofacitinib/upadacitinib) as advised by the rheumatologist as add on to 25 mg methotrexate |
| Upadacitinib | Experimental | 15mg Upadacitinib OD(oral) daily + 25mg Methotrexate oral once in a week Receives: Drug: JAK inhibitor(tofacitinib/upadacitinib) as advised by the rheumatologist as add on to 25 mg methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Disease activity score(DAS 28)
Change in Disease Activity Score-28 ranges from 0 to 10, with ≤2.6 indicates remission, 2.6-3.2 low disease activity, ≥ 3.2-5.1 moderate activity, ≥ 5.1 high disease activity.
Measured: From enrollment in the study to 6 months of treatment
Secondary outcomes (1)
Frequency & severity of opportunistic infections
Severity of opportunistic infections according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, which classifies adverse events from Grade 1 (mild) to Grade 5 (death)21.
- Grade 1 (Mild): Asymptomatic or mild infection; no or minimal intervention required
- Grade 2 (Moderate): Symptomatic infection requiring medical treatment (e.g., oral antibiotics/antivirals); no hospitalization
- Grade 3 (Severe): Severe infection requiring hospitalization or intravenous therapy
- Grade 4 (Life-threatening): Life-threatening infection requiring urgent intervention/ICU care
- Grade 5: Death related to infection
Measured: From enrollment in the study to 6 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start5 Jul 2026 (estimated)
- Primary completion5 Mar 2027 (estimated)
- Study completion10 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheikh Zayed Federal Postgraduate Medical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tahira Shaukat, Sheikh Zayed Federal Postgraduate Medical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636057
- Sponsor's protocol ID
- TERC/SC/INT/2026/47
- Status last verified
- Jun 2026
- First submitted
- 29 Apr 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Tofacitinib Versus Upadacitinib as Add-on to Methotrexate in Rheumatoid Arthritis; Comparative Clinical Study
- ClinicalTrials.gov ID
- NCT07636057
- Acronym / sponsor ID
- TERC/SC/INT/2026/47
- Conditions
- Rheumatoid Arthritis (RA)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheikh Zayed Federal Postgraduate Medical InstituteUniversity, hospital or other
- Study start
- 5 Jul 2026 (estimated)
- Primary completion
- 5 Mar 2027 (estimated)
- Study completion
- 10 May 2027 (estimated)
- First posted
- 9 Jun 2026 (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.
The goal of this interventional study is to learn, whether Tofacitinib or upadacitinib is more effective in treating the patients of Rheumatoid Arthritis. It will also learn about the safety of these two agents. The main questions it aims to answer are:
- Which JAK inhibitor (Tofacitinib or Upadacitinib) is more effective to improve the disease activity of Rheumatoid arthritis in Pakistani population?
- What is the Disease Activity scores, ESR, CRP, RA factor level of patients?
- What are the side effects of both drugs, during the study time?
Participants:
- Of Group A will be taking 5mg Tofacitinib oral daily for 6 months along with 25mg of once weekly dose of oral Methotrexate, whereas of Group B will be taking 15mg Upadacitinib oral daily for 6 months along with 25mg of once weekly dose of oral methotrexate.
- Will Visit the clinic once at 3 months and then 6 months for checkups and tests
- Will Keep a diary of any infection, treatment taken, duration of infection
- Will inform the researcher about any unusual side effect during the study
Detailed description
This study will be conducted in the Department of Pharmacology in collaboration with Rheumatology Department of Shaikh Zayed Medical Complex, Lahore.
The study population will consist of adult patients with diagnosis of RA on the basis of EULAR 2010 Classification Criteria: Moderate to severe disease activity indicated by DAS28 >3.2 and those with Inadequate response to methotrexate (MTX) characterized by Persistent active disease on ≥12 weeks of MTX treatment.
Sample size was estimated considering the following clinically significant variables: infection rate, thrombotic events, and cessation of treatment as a result of remission according to scientific publications. The maximum sample size was estimated among these methods in order to have adequate power.
If infection rate was considered as a key safety parameter, and taking into account the event rates of 0.7 and 1.2 per 100 patient-years for Tofacitinib and Upadacitinib, respectively22, the sample size would be 116 patients (58 per group) at 95% confidence interval and 80% power. In the case of thrombotic events with an assumed event rate of 0.2 and 0.4 per 100 patient-years23, the required sample size would be 100 patients (50 per group) at 95% confidence interval and 90% power.
Adult patients aged ≥18 years, regardless of gender will be included in the study. Whereas the following patients will not be included:
- Other autoimmune rheumatic disorders (SLE, psoriatic arthritis, AS, etc.)
- Administration of any biologic DMARD in the previous three months
- History of a serious infection (e.g., active tuberculosis or sepsis)
- Previous or existing history of recurrent infections or immunosuppressive status
- History of any malignancy in the last five years.
- Current chemotherapy, radiotherapy or intake of any genotoxic drug
- Severe liver impairment (e.g., ALT/AST >3× ULN)
- Severe renal impairment (e.g., estimated GFR <30 mL/min)
- Severe Haematological Abnormalities: Hb <8 g/dL, TLC <3,000 /mm³, Platelets <100,000 /mm³
- Past or present deep vein thrombosis or pulmonary embolism
- Pregnant or lactating women
- Women of reproductive age who are not practicing adequate contraception measures
Data collection procedure:
After the Evaluation by rheumatologist and prescribing the tofacitinib or Upadacitinib, an informed consent will be taken from the patient. Baseline investigations and history will be taken and added to the data collection sheet (Attached at the end). Patients will be followed vigilantly and then the clinical evaluation \& biochemical investigations will be recorded at 3 months and 6 months.
Statistical Analysis:
All analyses will be conducted according to the ITT principle. A per protocol analysis will also be performed as sensitivity analysis. Two-sided p ≤ 0.05 will be considered statistically significant.
Continuous variable will be presented as mean±SD/median (IQR) and categorical variables will be presented as frequency (%).
Comparison of proportion between groups will be performed using the Chi-square/Fisher's exact test and effect sizes will be calculated as Risk difference, relative risk (RR) with 95% confidence interval.
Change in DAS28 will be compared by using Independent sample t-test/Mann Whitney-U test. Repeated measures analysis (mixed model/ANOVA) will be used to see the groups and time effect simultaneously. ACR responses will be analyzed by using Chi-square test Comparison of incidence rate between groups will be performed using Chi-square/Fisher's exact test and rates will be presented as proportion and/or incidences per 100 patient years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tofacitinib | Experimental | Drug: JAK inhibitor(tofacitinib/upadacitinib) as advised by the rheumatologist as add on to 25 mg methotrexate5mg tofacitinib BD(oral) daily + 25mg Methotrexate oral once in a week |
| Upadacitinib | Experimental | Drug: JAK inhibitor(tofacitinib/upadacitinib) as advised by the rheumatologist as add on to 25 mg methotrexate15mg Upadacitinib OD(oral) daily + 25mg Methotrexate oral once in a week |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- • Adult patients aged ≥18 years, regardless of gender
Key exclusion criteria (12 listed)
- • Other autoimmune rheumatic disorders (SLE, psoriatic arthritis, AS, etc.)
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 |
|---|---|---|
| JAK inhibitor(tofacitinib/upadacitinib) as advised by the rheumatologist as add on to 25 mg methotrexateThere is no comparative study of tofacitinib with upadacitinib in Pakistan, as upadacitinib is recently been available here. There is no study yet in pakistan to compare the effectiveness and safety of these two JAK inhibitors in Pakistani population. | Drug | Tofacitinib, Upadacitinib |
Primary outcome
Change in the Disease activity score(DAS 28)
Time frame: From enrollment in the study to 6 months of treatment
Change in Disease Activity Score-28 ranges from 0 to 10, with ≤2.6 indicates remission, 2.6-3.2 low disease activity, ≥ 3.2-5.1 moderate activity, ≥ 5.1 high disease activity.
1 secondary outcome
Frequency & severity of opportunistic infections
Time frame: From enrollment in the study to 6 months of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
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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.
Dr Sadia Maqsood Awan Assistant Professor Pharmacology FPGMI Lahore, MBBS, M.phil,MHPE contact
Dr Mudassra yaseen HOD pharmacology FPGMI, Lahore, MBBS, M.phil, CMT, PhD contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing JAK inhibitor(tofacitinib/upadacitinib) as advised by the rheumatologist as add on to 25 mg methotrexate in people with Rheumatoid Arthritis (RA), run by Sheikh Zayed Federal Postgraduate Medical Institute.
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 1 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: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Sadia Maqsood Awan Assistant Professor Pharmacology FPGMI Lahore, MBBS, M.phil,MHPE (03335032495, sadia_maqsood_awan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Disease activity score(DAS 28) (time frame: From enrollment in the study to 6 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2026.