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Special Investigation in Patients With Ulcerative Colitis

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AbbVie

Status

Completed

Conditions

Ulcerative Colitis

Study type

Observational

Funder types

Industry

Identifiers

NCT01947816
P14-190

Details and patient eligibility

About

This investigation will be conducted to obtain the following information regarding the use of Humira 40 mg Syringe 0.8 mL for Subcutaneous Injection in patients with Ulcerative Colitis.

  1. Unknown adverse reactions (in particular, clinically significant)
  2. Incidence and conditions of occurrence of adverse reactions in clinical practice
  3. Factors likely to affect the safety and effectiveness

Enrollment

1,621 patients

Sex

All

Ages

Under 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients receiving Humira for the first time for the treatment of Ulcerative Colitis

Exclusion criteria

Contraindications according to the Package Insert include patients who have any of the following:

  • serious infections
  • tuberculosis
  • a history of hypersensitivity to any ingredient of Humira
  • demyelinating disease or a history of demyelinating disease
  • congestive cardiac failure

Trial design

1,621 participants in 1 patient group

Humira
Description:
Humira 40 mg (marketed product) eow for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration, for up to 52 weeks.

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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