NCT00573794 is a Phase 3 clinical trial of adalimumab in Ulcerative Colitis, sponsored by AbbVie (prior sponsor, Abbott).

Who is sponsoring NCT00573794?

NCT00573794 is sponsored by AbbVie (prior sponsor, Abbott).

What drugs are being tested in NCT00573794?

Interventions in NCT00573794: adalimumab.

What condition does NCT00573794 study?

NCT00573794 studies Ulcerative Colitis.

Is NCT00573794 still recruiting?

NCT00573794 is currently completed. Last updated 2 July 2021.

Are results published for NCT00573794?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-07-02 · How we verify

NCT00573794

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis

Completed Phase 3 Results posted Last updated 2 July 2021

What this trial tests

Phase 3 trial testing adalimumab in Ulcerative Colitis in 592 participants. Completed in 1 December 2016.

Timeline

28 November 2007

Primary endpoint
1 December 2016

1 December 2016

Quick facts

Lead sponsor	AbbVie (prior sponsor, Abbott)
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	592
Start date	28 November 2007
Primary completion	1 December 2016
Estimated completion	1 December 2016

Drugs / interventions tested

adalimumab (ADALIMUMAB) — full drug profile →

Conditions studied

Ulcerative Colitis — all drugs for Ulcerative Colitis →

Sponsor

AbbVie (prior sponsor, Abbott) — full company profile →

Who can join

18 and older, any sex, with Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Partial Mayo Score: Change From Baseline Over Time
Time frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
The Partial Mayo score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment \[PGA\]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Partial Mayo score indicates improvement.
Mayo Score: Change From Baseline Over Time
Time frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment \[PGA\]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.

Sponsor's own description

To assess the long-term safety and maintenance of response of adalimumab in subjects with ulcerative colitis who participated in and successfully completed M06-826 (NCT00385736) or M06-827 (NCT00408629).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis.
Ryan C, Sobell JM, Leonardi CL, Lynde CW, et al · · 2018 · cited 28× · PMID 29380251 · DOI 10.1007/s40257-017-0341-6
Dissecting Innate and Adaptive Immunity in Inflammatory Bowel Disease: Immune Compartmentalization, Microbiota Crosstalk, and Emerging Therapies.
Yue N, Hu P, Tian C, Kong C, et al · · 2024 · cited 9× · PMID 39634289 · DOI 10.2147/jir.s492079

Verify or expand the search:

Other trials of adalimumab

Trials testing the same drug.

NCT04230213 — A Comparative Study Between PF-06410293 and Humira® in Combination With Methotrexate in Participants With Active Rheumat · Phase 3 · completed
NCT04009668 — Tumor Necrosis Factor Inhibition in Focal Segmental Glomerulosclerosis and Treatment Resistant Minimal Change Disease · Phase 2 · completed
NCT03955861 — Ultrasound Enthesitis Response in Psoriatic Arthritis · completed
NCT03737708 — A Study Comparing Biologics + Methotrexate With Biologics + Tacrolimus in Patients With Rheumatoid Arthritis (RA) · Phase 4 · completed
NCT03316781 — Study of Efficacy and Safety of HLX03 in Subjects With Moderate to Severe Plaque Psoriasis · Phase 3 · completed

Other recruiting trials for Ulcerative Colitis

Currently open trials in the same condition.

NCT07185009 — A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Acti · Phase 3 · recruiting
NCT07265570 — Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA) · Phase 2 · recruiting
NCT07223424 — Patient Preference for Subcutaneous vs. Intravenous Immune Therapy · Phase 2 · recruiting
NCT06405087 — A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD · Phase 3 · recruiting
NCT07184996 — An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Activ · Phase 3 · recruiting

Other AbbVie (prior sponsor, Abbott) trials

Trials by the same sponsor.

NCT01609933 — A Study to Evaluate the Safety and Effect of Treatment With Experimental Antiviral Drugs in Combination With Peginterfer · Phase 2 · completed
NCT01657799 — Comparison of Veliparib and Whole Brain Radiation Therapy (WBRT) Versus Placebo and WBRT in Adults With Brain Metastases · Phase 2 · completed
NCT01736189 — Assessment of Clinical Effectiveness and Safety of Adalimumab and High Dose Methotrexate in Routine Clinical Practice · completed
NCT01620528 — A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Assoc · Phase 3 · completed
NCT01506947 — A Pilot Clinical Study Evaluating the Effect of Parathyroid Hormone (PTH) Lowering On Erythropoietin Consumption in Calc · Phase 4 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00573794 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie (prior sponsor, Abbott)
Last refreshed: 2 July 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00573794.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing