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Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease. (ADA-SWITCH)

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ClinicalTrials.gov Identifier: NCT04131322
Recruitment Status : Not yet recruiting
First Posted : October 18, 2019
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Brief Summary:
Loss of response of the Adalimumab biosimilar compared with the original drug.

Condition or disease Intervention/treatment Phase
Crohn Disease Ulcerative Colitis Drug: Amgevita 40Mg Solution for Injection Drug: HUMIRA 40Mg Solution for Injection Phase 4

Detailed Description:

A single-site Unicentric, randomized, parallel-group, non-inferiority open study including patients diagnosed with inflammatory bowel disease (Crohn's disease and Ulcerative Colitis) who were in clinical remission with Adalimumab original for at least 6 months prior to the start of the study.

A total of 216 patients with inflammatory bowel disease from the Inflammatory Unit of the Virgin Macarena University Hospital will be randomized 1:1 to receive the study drug, Adalimumab biosimilar (AMGEVITA®) subcutaneous 40mg every 15 days or maintain the original drug (Humira®) 40 mg subcutaneous every 15 days.

The dosage of the medication will be administrated according to the product's approved label by SmPC (Summary of Product's Characteristics)by technical file. Administration will be accepted every 7 days, if the patient after inclusion criteria is included with intensified dose.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Loss of Response of Adalimumab Biosimilar Compared With the Loss of Response of Adalimumab Original: Controlled, Randomized, Non-inferiority Open Study. "ADA-SWITCH Study"
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arm Intervention/treatment
Experimental: switch-cohort
Adalimumab biosimilar
Drug: Amgevita 40Mg Solution for Injection
Adalimumab 40Mg Solution for Injection
Other Name: AMGEVITA

Active Comparator: non-switchcohort
Adalimumab original
Drug: HUMIRA 40Mg Solution for Injection
Adalimumab 40Mg Solution for Injection
Other Name: HUMIRA




Primary Outcome Measures :
  1. Change from baseline to final follow-up in the response of the switch. [ Time Frame: From date of randomization until the date of first documented change from baseline status in concomitant steroids needed or increment in dose or frequency of adalimumab biosimilar or urgent surgery indication ever came first, assessed up to 13 months ]
    To assess if there is a change in the response of the switch (replacement) from Adalimumab original (Humira®) to Adalimumab biosimilar (Amgevita®) trhough the quantification of concomitant steroids needed or increment in dose or frequency of adalimumab biosimilar or urgent surgery indication


Secondary Outcome Measures :
  1. Compare the antibody formation rate. [ Time Frame: 0, 3, 6, 9, 12, 13 months ]
    Compare the antibody formation rate with Adalimumab(immunogenicity) after the switch.

  2. The score of the specific quality of life questionnaire [ Time Frame: 0, 3, 6, 9, 12, 13 months ]
    Compare the score of the specific quality of life questionnaire Short Inflammatory Bowel Disease Questionnaire (SIBDQ) in patients with inflammatory bowel disease before and after the switch.The minimum value is 1 and the maximum is 7, where higher scores means better outcome.

  3. The score of the Visual Analogue Scale (VAS) [ Time Frame: 0, 3, 6, 9, 12, 13 months ]
    Compare the score of the Visual Analogue Scale (VAS) of pain at the puncture site after the switch. The minimum value is 0 mm and the maximum value is 100 mm, where the higher score means a worse outcome.

  4. Maintenance of bioquimical remission trhough C-reactive protein [ Time Frame: 0, 3, 6, 9, 12, 13 months ]
    levels of C-reactive protein in blood (mg/L).

  5. Maintenance of bioquimical remission through Calprotectin values [ Time Frame: 0, 3, 6, 9, 12, 13 months ]
    levels of Calprotectin in blood (µg/g).

  6. Drug levels [ Time Frame: 0, 3, 6, 9, 12, 13 months ]
    Determination of drug levels in blood (µg/ml).

  7. Adverse Event [ Time Frame: 0, 3, 6, 9, 12, 13 months ]
    Proportion of patients who experience AE in each treatment group

  8. Hospital admission rate [ Time Frame: 0, 3, 6, 9, 12, 13 months ]
    Proportion of patients requiring hospital admissions related to a disease outbreak during follow-up.

  9. Surgery rate [ Time Frame: 0, 3, 6, 9, 12, 13 months ]
    Proportion of patients requiring surgery related to disease activity during follow-up.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be male or female over 18 years of age
  • Be a Patient with a previous confirmed diagnosis of Crohn´s disease an Ulcerative Colitis
  • Previous treated with original Adalimumab for at least 6 months with regular maintenance dose (40 mg every 15 days) and in clinical and biological remission.
  • Patients under treatment with intensified Adalimumab (40mg every 7 days or 80mg every 7 days) to maintain clinical and biological remission for at least 6 months.
  • Patients with oral mesalazine with a stable dose for more than 30 days.
  • Patients with immunosuppressive therapy (methotrexate, azathioprine) with a minimum intake time> 60 days.
  • Patients may be accepted with corticosteroids at the established doses:

prednisone <20mg / dl, budesonide <9mg / dl.

  • Patients who have a tuberculosis (TB) study (Mantoux / QuantiFERONTB test) updated in the last two year, with a negative result.
  • Patient with serology hepatitis B and C, updated at the beginning of the treatment with Humira®
  • Sign an informed consent document indicating that he/she understands the purpose of, and procedures required for, the study and are willing to participate in the study.

Exclusion Criteria:

  • Positive pregnancy test at the time of inclusion or during the follow-up period, as well as women who are breastfeeding
  • Patients with uncontrolled comorbidities, active cancer, diabetes mellitus, severe cardiovascular disease, obstructive pulmonary disease, serious active infections.
  • Patients with oral mesalazine initiated less than 30 days.
  • Patients with immunosuppressive therapy (methotrexate, azathioprine) with a minimum intake time of <60 days.
  • Patient with original Adalimumab who do not meet a minimum of 6 months of stable dose (40 mg every 7 or 15 days)
  • Patient on corticosteroid therapy at doses: prednisone> 20mg / dl, budesonide = 9mg / dl, or with IV corticoids within 14 days prior screening date.
  • Patients with mental disorders, alcohol / other substance abuse, or conditions that do not allow adherence to the study protocol.
  • Patients with active TB
  • Patients with defined Hepatitis B and C defined as:

HBV: hepatitis B surface antigen (HbsAg) positive together with positive HBV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR). HCV: HCV ribonucleic acid (RNA) detectable in any patient with positive anti-HCV antibody (IgG)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04131322


Contacts
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Contact: Federico Rosso Fernandez, Md PhD 0034 955013414 claram.rosso.sspa@juntadeandalucia.es
Contact: Federico Argüelles Arias, Md PhD 0034 955013414 farguelles@telefonica.net

Sponsors and Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Investigators
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Principal Investigator: Federico Argüelles Arias, Md PhD Universitary Hospital Virgen Macarena

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Responsible Party: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier: NCT04131322    
Other Study ID Numbers: AMGEVITA-HVM2019
First Posted: October 18, 2019    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:
Loss of response
Switching
Adalimumab original
Adalimumab biosimilar
Additional relevant MeSH terms:
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Crohn Disease
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colitis
Colonic Diseases
Adalimumab
Pharmaceutical Solutions
Anti-Inflammatory Agents
Antirheumatic Agents