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Clinical Trials

XELJANZ is approved to treat adults with moderate to severe rheumatoid arthritis when 1 or more TNF blockers did not work well or cannot be tolerated.

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.

Approximately

clinical study participants
XELJANZ was tested with and without methotrexate
Efficacy and safety evaluated in multiple studies

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

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:

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.

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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.

Results Of The Study

More than half (59%) of XELJANZ patients felt an improvement in their RA symptoms within 3 months.*

*Individual results may vary.

At 3 months, more than half of XELJANZ patients could more easily complete common daily activities, such as getting dressed, walking down stairs, and gripping household items.
XELJANZ reduced further joint pain and swelling caused by RA, even without the use of methotrexate.

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).

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).

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

At 6 months, XELJANZ patients experienced less joint damage progression than methotrexate patients.

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.

Talking To Your Doctor

If your current treatment is not working well enough to manage your RA symptoms, it’s important to speak up with your doctor. Every appointment is an opportunity to discuss symptom concerns, different treatment options, and how your disease is affecting some aspects of your daily activities. Use our list of questions to help start the conversation.

Get Helpful Questions

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