NCT01848561

A Long-Term Registry of an Active Drug in Patients With Moderately to Severely Active Ulcerative Colitis (UC)

Brief summary

This is a registry study to evaluate the long-term safety and effectiveness of an active drug in patients with moderately to severely active UC who are treated as recommended in the product label.

Interventional study

Status:
Recruiting
Conditions:
Ulcerative Colitis (UC)
Enrollment:
8250 patients
Protocol ID:
P11-282
Observational model:
Cohort
Time perspective:
Prospective

Would you like to know more about this trial?

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Eligibility criteria

Participant attributes:
Male and Female

Age:

From 18 Years to 99 Years.

Inclusion Criteria:

- For enrollment into the HUMIRA treatment group; adult patients with moderately to
severely active UC who has been prescribed HUMIRA therapy according to routine
clinical practice and meets one of the following:

1. Is currently taking HUMIRA therapy and has received at least 8 weeks of therapy;
OR

2. Is entering after participation in an Abbott or AbbVie sponsored UC study and;
has received continuous HUMIRA therapy since initiation of therapy

- For enrollment into the IMM treatment group; adult patients with moderately to
severely active UC who has been prescribed IMM therapy, is currently taking IMM
therapy, and has received at least 12 consecutive weeks of IMM therapy

- Patients capable of and willing to grant authorization for use/disclosure of data
being collected and provided to AbbVie prior to any registry-related data being
collected, and to comply with the requirements of the Registry protocol

Exclusion Criteria:

- Patients on IMM therapy without a concurrent biologic if they cannot continue to be
treated with IMM therapy or

- Patients who are being treated with any investigational agents and/or approved
biologics other than Humira.

All the cities where the clinical studies are located

Edmonton - T5H 4B9

Edmonton - T6G 2X8

New Westminster - V3L 3W5

Surrey - V3V 1Z1

Vancouver - V5Z 4E8

Vancouver - V6Z 2K5

Victoria - V8V 3M9

Halifax - B3H 1V7

Brampton - L6S 0C1

Guelph - N1H 3R3

Hamilton - L8N 1Y2

London - N6A 5A5

Oshawa - ON L1G 2B9

Ottawa - K1H 8L6

Ottawa - K1K 0T2

Toronto - M53 TA9

Montreal - H1T 2M4

Montréal - H2X 0A9

Sherbrooke - J1H 5N4

Saskatoon - S7N 0W8

Fredericton - E3B 5N5