Treatment of Chinese Adult Subjects With Moderate to Severe Crohn's Disease With Tabellvi®
Phase 4 · Testing TyboWe® Adalimumab Injection · 7 sites · Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing TyboWe® Adalimumab Injection (a drug) as a possible treatment. Condition(s) listed: Crohn's Disease.
It is open-label: participants know what they are receiving.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 18 to 70
- Any sex
Some of the main requirements, copied from the record:
- The subject must sign the informed consent form.
- Aged 18 to 70 years inclusive, no gender restriction.
- Subjects with definite diagnosis of Crohn's disease in accordance with Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (Guangzhou, 2023), presenting moderate to severe active Crohn's disease with inadequate response,…
- Adult patients with Crohn's disease who are prescribed Tabellvi® Adalimumab Injection by physicians following thorough risk-benefit assessment.
- Female subjects of childbearing potential must agree to use one contraceptive method approved by the investigator.
There are also 21 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 50 participants are expected to take part.
- The study has 1 group.
- Start date: 2026-09-23.
- Main results expected around 2028-12 (estimate from the record).
- 7 study sites listed (1 marked recruiting) in China.
Groups in this study
- Tabellvi® Adalimumab Injection (listed as: experimental group)
Main thing being measured
- Serious Adverse Event (SAE) (Baseline up to 54 weeks)
- Adverse Event (AE) (Baseline up to 54 weeks)
- Adverse Drug Reaction (ADR) (Baseline up to 54 weeks)
In the researchers’ words
This is a post-marketing real-world study designed to evaluate the efficacy and safety of Tabellvi® (Adalimumab Injection) in Chinese adult subjects with moderate to severe active Crohn's disease via a single-arm trial. A total of 50 subjects are planned to be enrolled. The primary endpoints include the incidence rates of adverse events (AEs), serious adverse events (SAEs), adverse drug reactions (ADRs) and serious…
Words you might see
- Bilirubin: a yellow substance measured in blood; high levels can be a sign of liver or bile-duct problems.
- CDAI: Crohn's Disease Activity Index, a score of how active Crohn's disease is.
- Remission: a period when the disease is quiet or under control.
- Anti-TNF: a group of biologic medicines (such as infliximab or adalimumab) used in IBD.
- Fistula: an abnormal tunnel between two parts of the body, which can happen in Crohn's disease.
- Stricture: a narrowing (of the bowel or of a bile duct).
- Ileal pouch (IPAA): an internal pouch made from the small intestine after the colon is removed; pouchitis is inflammation of it.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Crohn's Disease |
| Lead sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
| Enrollment | 50 (estimated) |
| Start date | 2026-09-23 |
| Primary completion (est.) | 2028-12 |
| First posted | 2026-06-23 |
| Last updated | 2026-09-24 |
| Official title | A Multicenter, Single-Arm Study to Evaluate the Effectiveness and Safety of Tabellvi® (Adalimumab) in Chinese Adult Subjects With Moderate to Severe Active Crohn's Disease in the Real-World Setting |
| ClinicalTrials.gov ID | NCT07663526 |
Interventions
- TyboWe® Adalimumab Injection (Drug)
Adalimumab is a human anti-tumour necrosis factor-alpha monoclonal antibody that inhibits the downstream inflammatory cascade by blocking TNF-α, a core inflammatory factor in psoriasis.
Full eligibility criteria (from the record)
Inclusion Criteria: * The subject must sign the informed consent form. * Aged 18 to 70 years inclusive, no gender restriction. * Subjects with definite diagnosis of Crohn's disease in accordance with Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (Guangzhou, 2023), presenting moderate to severe active Crohn's disease with inadequate response, intolerance or contraindication to adequate glucocorticoid and/or immunosuppressant therapy. * Adult patients with Crohn's disease who are prescribed Tabellvi® Adalimumab Injection by physicians following thorough risk-benefit assessment. * Female subjects of childbearing potential must agree to use one contraceptive method approved by the investigator. Exclusion Criteria: * Subjects who are not suitable for treatment with Tabellvi® Adalimumab Injection based on the prescribing information of Tabellvi® Adalimumab Injection and the judgment of the treating physician. * Female subjects who are pregnant or breastfeeding, or who plan to become pregnant during the study period. * Subjects with hypersensitivity to any component of Tabellvi® Adalimumab Injection. * Subjects with active, chronic or recurrent infections, or a medical history of invasive infections (e.g., listeriosis, histoplasmosis). * Subjects with active infections requiring intravenous anti-infective therapy within 30 days prior to the first dose, or those who have received oral anti-infective drugs within 14 days prior to the first dose. * Subjects with active tuberculosis infection; or latent tuberculosis infection without adequate treatment; subjects infected with human immunodeficiency virus (HIV); subjects positive for hepatitis C virus antibody (HCV Ab) indicating previous or current infection; subjects positive for hepatitis B surface antigen (HBsAg), or positive for total hepatitis B core antibody (total Hepatitis B core Ab) with positive hepatitis B virus (HBV)-DNA polymerase chain reaction test result. * Subjects with syphilis infection requiring treatment. * Subjects with moderate to severe heart failure (NYHA Class III/IV), recent cerebrovascular accident, or other medical conditions that may put the subject at risk by participating in this study. * Subjects with current evidence of dysplasia or a history of malignant tumors (including lymphoma and leukemia), except cured non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma or localized cervical carcinoma in situ. * Subjects with a history of demyelinating diseases (including myelitis), or neurological symptoms suggestive of demyelinating diseases. * Subjects who have undergone intestinal resection within the past 6 months, or plan to undergo intestinal resection at any time in the future. * Subjects receiving total parenteral nutrition (TPN), or planning to receive TPN at any time during the study period. * Subjects with an ostomy or an ileal pouch-anal anastomosis (IPAA) pouch. * Subjects with internal or external fistulas, except perianal fistulas without abscess. * Subjects with known symptomatic obstructive intestinal strictures. * Subjects diagnosed with ulcerative colitis or indeterminate colitis. * Subjects with any of the following abnormal laboratory or other examination results during the screening period: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 1.5 times the upper limit of the reference range; white blood cell count < 3.0×10⁹/L; electrocardiogram (ECG) with clinically significant abnormalities; total bilirubin ≥3 mg/dL (isolated elevated indirect bilirubin caused by Gilbert's syndrome excluded); serum creatinine >1.6 mg/dL. * Subjects with other clinically significant abnormal laboratory test results (other than those listed above) identified by the investigator during screening. * Subjects who have received other tumor necrosis factor-alpha (TNF-α) inhibitor therapy within 12 weeks before receiving the first dose of Tabellvi® Adalimumab Injection. * Subjects currently participating in another clinical study. * Subjects deemed unsuitable for participation in this trial by the investigator.
Locations (7)
| Site | City | Country | Site status |
|---|---|---|---|
| Fuyang People's Hospital | Fuyang, Anhui | China | Not yet recruiting |
| The Second Affiliated Hospital of Zhengzhou University | Zhengzhou, Henan | China | Not yet recruiting |
| Zhoukou Central Hospital | Zhoukou, Henan | China | Not yet recruiting |
| Huai'an First People's Hospital | Huaian, Jiangsu | China | Not yet recruiting |
| Yancheng No.1 People's Hospital | Yancheng, Jiangsu | China | Not yet recruiting |
| Meihekou Central Hospital | Meihekou, Jilin | China | Not yet recruiting |
| Shanghai Jiao Tong University School of Medicine, Renji Hospital | Shanghai, Shanghai Municipality | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.