Clinical Trials

Clinical Trials

The efficacy and safety of XELJANZ^® (tofacitinib) were tested in 6 clinical trials that included adult patients with moderate to severe rheumatoid arthritis (RA). In each study, participants were divided randomly into treatment groups, and 1,589 participants were treated with XELJANZ 5 mg twice daily.

Patients in 5 of the 6 clinical trials had moderate to severe RA, which is defined as having:

• At least 6 tender/painful joints
• At least 6 swollen joints
• Lab test results that indicated inflammation in joints

Two of the clinical trials required patients to have 3 or more joint erosions or a lab test result indicating RA.
These studies measured if XELJANZ:

• Reduced joint pain and swelling
• Improved the ability to accomplish certain daily activities. Improvement in physical function was measured by the Health Assessment Questionnaire Disability Index (HAQ-DI), which assesses the ability to complete different activities, such as dressing and grooming, arising, eating, walking, hygiene, reaching and gripping.
• Affected the progression of structural joint damage (in 2 of the studies)

Common side effects of XELJANZ in rheumatoid arthritis patients include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, nasal congestion, sore throat, runny nose (nasopharyngitis), and high blood pressure (hypertension). Learn more about the Most Important Information you should know about XELJANZ.

The ORAL Solo Study

ORAL Solo was a study that included adult patients with moderate to severe RA in whom biologic or nonbiologic DMARDs did not work well or could not be tolerated. Patients took either XELJANZ alone or a placebo alone. At 3 months, patients who received placebo were switched over to XELJANZ.

• At 2 weeks, 30% of XELJANZ patients (71 out of 240) and 12% of placebo patients (14 out of 119) had an improvement in their RA signs and symptoms as measured by ACR20 response criteria.
• At 3 months, 59% of XELJANZ patients (143 out of 243) and 25% of placebo patients (31 out of 122) experienced an improvement in their RA signs and symptoms as measured by ACR20.
• At 6 months, 69% of XELJANZ patients (168 out of 243) had an improvement in their RA signs and symptoms as measured by ACR20.
• At 3 months, 60% of XELJANZ patients (143 out of 240) and 39% of placebo patients (47 patients out of 120) experienced improvement in physical function as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI).

Results Of The Study

Common side effects of XELJANZ in rheumatoid arthritis patients include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, nasal congestion, sore throat, runny nose (nasopharyngitis), and high blood pressure (hypertension). Learn more about the Most Important Information you should know about XELJANZ.

The ORAL Start & ORAL Scan Studies

Based on two studies, XELJANZ was shown on X-rays to help reduce further joint damage.

The ORAL Start Study

ORAL Start was a study that included adult patients with moderate to severe RA who hadn't taken methotrexate prior to the study. Patients took either XELJANZ alone or methotrexate alone.

At 6 months, patients who took XELJANZ had less progression of RA joint damage than patients who took methotrexate, as measured by the modified Total Sharp Score (mTSS).

• At 6 months, 73% of patients treated with XELJANZ 5 mg twice daily experienced no radiographic progression of joint damage compared to 55% of patients taking methotrexate.

The ORAL Scan Study

ORAL Scan was a study of adult patients with moderate to severe RA in whom methotrexate did not work well. Patients took either XELJANZ and methotrexate or placebo and methotrexate.

At 6 months, patients who took XELJANZ and methotrexate had less progression of RA joint damage than patients who took placebo and methotrexate, as measured by the modified Total Sharp Score (mTSS).^†

• At 6 months, 84% of patients treated with XELJANZ 5 mg twice daily plus methotrexate experienced no radiographic progression of joint damage compared to 74% of patients who took placebo plus methotrexate.^†

^†There is a possibility that the difference between treatments may have been due to chance alone and not due to XELJANZ, so the results were not considered significant.

Results Of The Studies

Less Joint Damage

Common side effects of XELJANZ in rheumatoid arthritis patients include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, nasal congestion, sore throat, runny nose (nasopharyngitis), and high blood pressure (hypertension). Learn more about the Most Important Information you should know about XELJANZ.