N/A
Completed N=1,593
Special Investigation in Patients With Ulcerative Colitis
Source: ClinicalTrials.gov NCT01947816 ↗Enrolled (actual)
1,593
Serious AEs
4.9%
Results posted
May 2019
Primary outcomePrimary: Number of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions — 276; 74 Participants
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions |
276; 74 | — |
| SECONDARY Change From Baseline in CRP Levels Over Time |
0.64; 0.53; 0.38; 0.29; 2.10 | — |
| SECONDARY Change From Baseline in Mayo Score Over Time |
-4.4; -4.8; 0.8; -3.3 | < 0.0001 sig |
| SECONDARY Mayo Endoscopic Sub-Score Over Time |
18; 21; 16; 6; 35; 34 | — |
| SECONDARY Change From Baseline in Partial Mayo Score Over Time |
-2.1; -2.5; -2.8; -3.0; -3.5; -0.7 | < 0.0001 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01947816). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.