Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Two Treatment Modules in Chinese Subjects With Moderate to Severe Crohn's Disease

Crohn's Disease Clinical Trial

Official title:

A Phase 2, Randomized, Double-Blind, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Two Adalimumab Dosing Regimens in Chinese Subjects With Moderately to Severely Active Crohn's Disease and Elevated High-Sensitivity C-reactive Protein

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02015793
• Other study ID #: M14-232
• Status: Completed
• Phase: Phase 2
• Start date: December 2013
• Est. completion date: February 2015

Study information

• Verified date: April 2016
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the efficacy, safety, and pharmacokinetics of adalimumab following subcutaneous (SC) administration of 2 dosing regimens in Chinese subjects with Crohn's disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Subjects of Chinese descent with full Chinese parentage.

2. Diagnosis of Crohn's disease (CD) for at least 3 months prior to Week 0 confirmed by endoscopy, radiologic evaluation, and/or histology during the Screening Period.

3. Crohn's Disease Activity Index (CDAI) = 220 and = 450 despite treatment with oral corticosteroids and/or immunosuppressants.

4. Subject has a negative Tuberculosis (TB) Screening Assessment.

Exclusion Criteria:

1. Subject with ulcerative colitis or indeterminate colitis.

2. Subject who has had a surgical bowel resection within the past 6 months or who is planning any resection at any time point in the future.

3. Subject with an ostomy or ileoanal pouch.

4. Subject who has short bowel syndrome.

5. Subject with symptomatic known obstructive strictures.

6. Subject with an internal or external fistula (with the exception of an anal fistula without abscess).

7. Chronic recurring infections or active TB.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Biological:
• Adalimumab
Adalimumab pre-filled syringe, administered by subcutaneous injection.
• Placebo for adalimumab
Placebo for adalimumab pre-filled syringe, administered by subcutaneous injection to maintain double-blind.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

References & Publications (1)

Wu KC, Ran ZH, Gao X, Chen M, Zhong J, Sheng JQ, Kamm MA, Travis S, Wallace K, Mostafa NM, Shapiro M, Li Y, Thakkar RB, Robinson AM. Adalimumab induction and maintenance therapy achieve clinical remission and response in Chinese patients with Crohn's dise — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Subjects Positive for Anti-Adalimumab Antibodies (AAA) From Baseline to Week 8	Serum samples with adalimumab concentration below 2 µg/mL were selected for AAA analyses. Samples were considered AAA positive if the measured AAA concentration was above 2 µg/mL. A subject was considered to be AAA positive if the subject had at least one AAA positive sample observed within 30 days following the subject's last adalimumab dose. No samples were tested because all samples had adalimumab concentrations >2 µg/mL.	Baseline (Week 0) to Week 8
Primary	Mean Serum Adalimumab Concentration at Week 8	Blood samples were drawn prior to drug administration. Adalimumab concentrations in serum were determined using a validated enzyme-linked immunosorbent assay (ELISA) method.	Week 8
Secondary	Number of Participants With Potentially Significant Hematology Parameters During Administration of Adalimumab	The number of participants with an abnormal laboratory result meeting Common Toxicity Criteria (CTC) Version 3.0 (or later) of Grade 3 or higher is summarized. n=the number of participants with CTC Grade <3 at baseline and a post-baseline value for each parameter.	26 weeks
Secondary	Number of Participants With Potentially Significant Clinical Chemistry Parameters During Administration of Adalimumab	The number of participants with an abnormal laboratory result meeting Common Toxicity Criteria (CTC) Version 3.0 (or later) of Grade 3 or higher is summarized.	From Week 0 to Week 26
Secondary	Number of Participants With Potentially Significant Vital Signs Parameters During Administration of Adalimumab	Blood pressure and pulse were measured while the participant was sitting. The number of participants with a postbaseline vital sign result that meets Common Toxicity Criteria (CTC) version 3.0 (or later) Grade 3 or higher and is also more extreme than the baseline value is summarized. Terms abbreviated in the table include systolic blood pressure (SBP) and diastolic blood pressure (DBP). Increase and decrease are signified by ? and ?, respectively.	26 weeks
Secondary	Number of Participants With Adverse Events (AEs)	An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (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 participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs or TESAE) are defined as any event that began or worsened in severity after the first dose of study drug. The investigator assessed the relationship of each event to the use of study drug as either Reasonable possibility or No reasonable possibility of being related to study drug.; For more details on adverse events please see the AE section below.	35 weeks
Secondary	Percentage of Participants Who Achieved Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) Every 2 Weeks up to Week 26	CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score of 220 to 450 reflects moderate to severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.	Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26
Secondary	Percentage of Participants Who Achieved Clinical Response (CDAI Decrease = 70 From Week 0) Every 2 Weeks up to Week 26	CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score of 220 to 450 reflects moderate to severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.	Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26
Secondary	CDAI: Mean Change From Baseline to Each Visit	CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. Scores range from 0 to approximately 600. A score below 150 indicates remission and a score of 220 to 450 reflects moderate to severe disease. Last observation carried forward (LOCF) for missing CDAI observations was used.	Baseline (Week 0) and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26
Secondary	High-sensitivity C-reactive Protein (hsCRP): Median Change From Baseline (Week 0) to Week 26	hsCRP was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 3 mg/L, slightly increasing with age. LOCF was used for missing data.	Baseline (Week 0) and Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and 26
Secondary	Fecal Calprotectin: Change From Baseline (Week 0) to Week 8	Stool samples for fecal calprotectin were collected before study drug administration when possible. Decreases in calprotectin are associated with decreased inflammation in the gastrointestinal tract. LOCF was used for missing data.	Baseline (Week 0) and Weeks 4 and 8

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