A Phase 4 interventional study of JAK inhibitor(tofacitinib/upadacitinib) as advised by the rheumatologist as add on to 25 mg methotrexate in Rheumatoid Arthritis (RA), sponsored by Sheikh Zayed Federal Postgraduate Medical Institute. Not yet recruiting. Open to participants aged 20 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by Sheikh Zayed Federal Postgraduate Medical Institute · Phase 4, Interventional, and Treatment
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:
Participants:
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:
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.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's planned enrollment of 100 is close to the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Sheikh Zayed Federal Postgraduate Medical Institute is the lead sponsor of 15 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other rheumatic disorders (SLE, psoriatic arthritis, AS, etc.)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
5mg tofacitinib BD(oral) daily + 25mg Methotrexate oral once in a week
Drug: JAK inhibitor(tofacitinib/upadacitinib) as advised by the rheumatologist as add on to 25 mg methotrexate
15mg Upadacitinib OD(oral) daily + 25mg Methotrexate oral once in a week
Drug: JAK inhibitor(tofacitinib/upadacitinib) as advised by the rheumatologist as add on to 25 mg methotrexate
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.
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.
Time frame: From enrollment in the study to 6 months of treatment
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
Time frame: From enrollment in the study to 6 months of treatment
Lipid profile
Change in Lipid Profile; Total cholesterol \>200 mg/dL , LDL \>130 mg/dL ,HDL \<40 mg/dL, Triglycerides \>150 mg/dL
Time frame: From enrollment in the study to 6 months of treatment
No study locations are listed for this record.
Start is estimated for Jul 2026; primary completion for Mar 2027, 8 months later.
Of 79 non-industry phase 4 interventional studies under Arthritis, Rheumatoid, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 92. This study's planned 8 months is below that.
Counting every sponsor, half of 104 studies reached it within 42 months; a quarter within 25 and three quarters within 74.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Sheikh Zayed Federal Postgraduate Medical Institute