Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and safety of the adalimumab biosimilar Amgevita in subjects with moderate to severe active chronic inflammatory bowel diesease (Crohn's disease and ulcerative colitis)

Phase 1

• Conditions: MedDRA version: 20.1Level: PTClassification code 10021972Term: Inflammatory bowel diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2019-003662-40-DE
• Lead Sponsor: niversitätsklinikum Erlangen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-22
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

1. Age: 18-80 years
2. Male or female
3. Subject is mentally able to understand the nature and content of the clinical trial and to follow the instructions of the study staff
4. Existence of a written informed consent
5. Diagnosis of chronic inflammatory bowel disease with indication for initial treatment with adalimumab in subjects with moderate to high grade disease activity and clinically insufficient response to or contraindication for systematic therapy with corticosteroids and/ or immunosuppressants, as defined below:
Current diagnosis of moderate to severe, ulcerative colitis with a total Mayo score of =6 (endoscopic subscore of =2) that has been confirmed in accordance with the current guidelines of the DGVS and ECCO and has been in existence for at least 3 months.
OR
Current diagnosis of a moderate to severe active M. Crohn with a Harvey-Bradshaw index of =8 months, which has been confirmed in accordance with the current guidelines of the DGVS and ECCO and has been in existence for at least 3 months.
AND
insufficient response or intolerance to conventional therapy (including oral 5-ASA supplements, oral glucocorticoids, azathiopurine, 6-mercaptopurine or methothrexate)
6. If concomitant therapy is necessary, then under the following conditions:
a. Systemic therapy with glucocorticoids: stable dosage for at least two weeks before screening
b. MMX budesonide (9 mg/day), stable osage for 4 weeks before screening
c. 5-aminosalicylates: stable dosage for at least two weeks and initiated for at least 8 weeks before screening
d. Immunosuppressants (except ciclosporin A and tacrolimus): therapy for at least three months and stable dosage for at least four weeks before screening
7. Existence of endoscopic diagnostics taking into account the individual infestation pattern of the patient. The last endoscopic findings may have been collected no more than 12 weeks before the screening.
8. Female participants of child bearing potential must also meet at least one of the following criteria:
- menopause (at least 12 months of natural amenorrhea or six months of amenorrhea with serum-FSH >40mU/ml) or
- condition after ovarectomy or hysterectomy on both sides for at least six weeks before the screening date (visit 1, day -7-6 days) or
- Regular, correct and reliable use of a method of contraception with a failure rate of 1% per year (e.g. implants, depot syringes, intrauterine pessar, hormonal spirals) or
- partner's vasectomy.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 62
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Known contraindications for adalimumab therapy:
- Known hypersensitivity to any of the ingredients of the investigational medicinal product or to medicinal products with a similar chemical structure
- Moderate to severe heart failure (NYHA III/IV).
- Active tuberculosis.
- Severe acute infection including sepsis.
- Acute opportunistic infections including invasive fungal infections.
2. Acute or chronic infection with hepatitis B
3. Known demyelinating diseases of the central and peripheral nervous system (e.g. multiple sclerosis, Guillain-Barré syndrome)
4. Malignant disease (active malignancy under ongoing oncological therapy or a recent malignancy with moderate to high risk of recurrence within the last 5 years prior to screening)
5. The existence of another serious disease which, at the discretion of the investigator would result in a disproportionate risk to the patient concerned
6. Pregnancy and lactation
7. Administration of other anti-TNF-Ak therapies, ustekinumab, vedolizumab or tofacitinib within the last 4 weeks prior to study inclusion
8. Administration of ciclosporin A or tacrolimus within the last 8 weeks prior to study inclusion in a non-stable dose
9. Therapy with Anakinra or Abatacept
10. Planned surgical intervention during the study period such as colectomy, installation of an ileo-anal pouche, an ileorectostomy or an ileostoma
11. Persons who are dependent or employed by the sponsor or investigator.
12. Planned longer stay outside the region, which prevents compliance with the visit plan.
13. Participation in another clinical trial or administration of an unauthorised active substance within the last 4 weeks prior to the screening date.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified