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UpadacitinibWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)


Name (Synonyms) Correlation
drug1844 Placebo for Upadacitinib Wiki 1.00

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D003424 Crohn Disease NIH 0.50

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0100280 Crohn's disease HPO 0.50

There is one clinical trial.

Clinical Trials


1 A Multicenter, Randomized, Double-Blind, Placebo-Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Crohn's Disease Who Completed the Studies M14-431 or M14-433

A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.

NCT03345823 Crohn's Disease Drug: Upadacitinib Drug: Placebo for Upadacitinib
MeSH:Crohn Disease
HPO:Crohn's disease

Primary Outcomes

Description: Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.

Measure: Sub-Study 1: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI)

Time: Week 52

Description: Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) from Baseline.

Measure: Sub-Study 1: Percentage of Participants with Endoscopic Response

Time: Week 52

Description: An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. For more details on adverse events please see the Adverse Event section.

Measure: Sub-Study 2: Number of Participants with Adverse Events

Time: Through Week 240

Secondary Outcomes

Description: Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.

Measure: Sub-Study 1: Percentage of Participants with Clinical Remission per Patient-Reported Outcomes (PROs)

Time: Week 52

Description: Decrease of at least 100 points in CDAI from Baseline.

Measure: Sub-Study 1: Percentage of Participants Achieving Clinical Response 100 (CR-100)

Time: Week 52

Description: This is assessed in participants taking corticosteroids at Baseline. Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.

Measure: Sub-Study 1: Percentage of Participants who Discontinue Corticosteroid Use at Least 90 Days Prior to Week 52 and Achieve Clinical Remission, in Participants Taking Corticosteroids at Baseline.

Time: Week 52

Description: Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score. Endoscopic remission is defined per SES-CD.

Measure: Sub-Study 1: Percentage of Participants with Clinical Remission per CDAI and Endoscopic Remission

Time: Week 52

Description: CDAI remission is defined as CDAI < 150.

Measure: Sub-Study 1: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI)

Time: Through Week 52

Description: Endoscopic remission is defined per Simplified Endoscopic Score for Crohn's Disease (SES-CD).

Measure: Sub-Study 1: Percentage of Participants with Endoscopic Remission

Time: Week 52

Description: The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.

Measure: Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ)

Time: Baseline (Week 0) to Week 52

Description: The FACIT-F questionnaire was developed to assess fatigue.

Measure: Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)

Time: Baseline (Week 0) to Week 52

Description: This is assessed by reviewing participant's hospitalization data.

Measure: Sub-Study 1: Percentage of Participants with Hospitalizations due to Crohn's Disease (CD)

Time: Week 52

Description: EIMs are defined as manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.

Measure: Sub-Study 1: Percentage of Participants with Resolution of Extra-Intestinal Manifestation (EIMs) , in Participants with EIMs at Baseline

Time: Week 52


Related HPO nodes (Using clinical trials)