A single-center, randomized, controlled study on the effect of proactive therapeutic drug monitoring on the efficacy and cost of adamumab in the treatment of Crohn's disease

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000036845

Enrollment

Unknown

Registered

2020-08-25

Start date

2021-01-01

Completion date

Unknown

Last updated

2020-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease

Interventions

Proctive treatment drug monitoring group:In the proactive TDM group, adamumab is 160mg at week 0, 80mg at week 2, and 40mg once every two weeks from week 4 until week 8. Adalimumab serum trough concen

Reactive treatment drug monitoring group:In the reactive TDM group, adamumab is 160mg at week 0, 80mg at week 2, and 40mg once every two weeks from week 4 until week 8. Clinical response is assesed a

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years old; 2. Diagnosed as CD for at least 3 months before week 0; 3. The Crohn's disease activity index (CDAI) 220 to 450 after treatment with oral glucocorticoids and/or immunosuppressive agents; 4. The tuberculosis screening results of the subjects were negative; 5. Subjects are able and willing to provide written informed consent and comply with the requirements of this study protocol; 6. No biological agents were used within 8 weeks before enrollment.

Exclusion criteria

Exclusion criteria: 1) Subjects with ulcerative colitis or uncertain colitis; 2) Subjects who have had a surgical bowel resection in the past 6 months or plan to have any resection at any time in the future; 3) Subjects with short bowel syndrome; 4) Subjects with known symptoms of obstructive stenosis; 5) Pregnant women and lactating women; 6) Subjects who are in the period of acute or chronic infection of the whole body, or have a history of active tuberculosis or hepatitis; 7) Subjects with malignant tumors; 8) Subjects with severe heart, liver, kidney and other organs and systemic diseases; 9) When other researchers consider that the experimental drug is not suitable for use.

Design outcomes

Primary

Measure	Time frame
The proportion of patients in clinical remission at 52 week;	—

Countries

China

Contacts

Public ContactWensong Ge

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

gewensong@126.com+86 15801873708

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026