Investigating the safety of adalimumab when administered in subjects with Crohn*s Disease as well as evaulating the efficacy of adalimumab for the induction and maintenance of clinical remission and fistula closure in subjects with moderate to…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The study variables for safety are Adverse Events, laboratory data and the
physical exams. For the efficacy they are the Harvey-Bradshaw score, fistula
closure, SIBDQ, WPAI, external disease manifestations and unscheduled
inpatient*s and hospital visits and admissions.
Secondary outcome
Not applicable.
Background summary
Despite existing treatment methods for Crohn*s Disease a lot of patients still
suffer from the symptoms of Crohn*s Disease. Anti-tumor necrosis factor therapy
has proven it*s value in the treatment of Crohn*s Disease. A lot of patients
are becoming intolerant, allergic or insensitive to this therapy due to the
forming of antibodies. Adalimumab is fully human and is not expected to have
this adverse event. Also, adalimumab can be given at home contrary to the
anti-TNF therapy used now. By means of this study the safety and efficacy of
adalimumab for the induction and maintenance of clinical remission in subjects
with moderate to severe Crohn*s Disease will be researched. The results are
important to compare the efficacy of adalimumab with the existing anti-TNF
therapy, with the expectation that adalimumab is as effective without the
occurance of intolerance, allergy or insensitivity.
Study objective
Investigating the safety of adalimumab when administered in subjects with
Crohn*s Disease as well as evaulating the efficacy of adalimumab for the
induction and maintenance of clinical remission and fistula closure in subjects
with moderate to severe Crohn*s Disease and evaluating the impact of adalimumab
on external disease manifestations and patient reported outcomes.
Study design
A multi-center study.
Intervention
Patients receive at randomisation: 160 mg adalimumab, at week 2 80 mg
adalimumab and as of week 4 40 mg adalimumab every other week. Adalimumab will
be administered as 40 mg (0,8 ml) adalimumab per subcutaenous injection with an
injectionpen.
Study burden and risks
The subjects will participate in the study for a period of 20 weeks at the
most, followed by a Compassionate Use Program until adalimumab has been
approved and reimbursed. During the first 20 Weeks study, the subject will come
to the hospital 7 times in connection with the study. If desired, the patient
will remain in the study and he/she will come to the hospital only once every
12 weeks until the moment that adalimumab will be reimbursed by the insurance.
If the investigator deems it necessary, extra visits can be scheduled. Seventy
days after any last injection with adalumimab, the subject will be contacted by
telephone.
During the screening visit an ECG and x-rays of the chest will be made of the
subject. During the x-rays of the chest the subject will be exposed to a small
amount of radiation. This radiation is not considered a significant risk.
During the screening visit a PPD (or Mantoux) and a C Difficile test will be
done also. At all visits the subject will undergo a physical exam and blood and
urine will be collected. The drawing of blood can lead to fainting, infections
of the artery, pain, bruising and infection. Also, a bleeding can occur at the
injection site.
The subject will be asked to keep a dosing form, a form for adverse events and
a medication diary during the study. The subject will also be asked to fill out
two questionaires six times.
The subject may experience adverse events when the study drug is used. The most
common adverse events of adalimumab were reactions at the injection site.
Subjects suffered from redness, itching, bruising, pain and/or swelling of the
injection site. Most injection site reactions were described as mild, and most
of them dissapeared without having to stop using the medication. In this study
a pre-filled pen will be used instead of a pre-filled syringe. It is expected
that previously mentioned adverse events will occur less.
In the rheumatoid artritis studies, in which the subjects with adalimumab were
compared to subjects with placebo (injection with a non-active substance), the
following adverse events occurred more frequently in the adalimumab group, with
a percentage of less than 5%: upper respiratory infection, headache, rash,
sinusitis, accidental injuries, nausea, abdominal pain, back pain, urinary
tract infection, high blood pressure and flu syndrome.
Women of childbearing potential should use a reliable contraceptive method as
described in the protocol.
The use of certain medications (combinations) is not permitted if the subject
is participating in the study. This medication is described in the protocol.
Knollstr. 50
67061 Ludwigshafen
Germany
Knollstr. 50
67061 Ludwigshafen
Germany
Listed location countries
Age
Inclusion criteria
1. Diagnosis of moderate to severe Crohn's Disease confirmed by endoscopy or
radiologic evaluation for greater than 4 months (16 weeks).
2. Inadequate response to conventional therapy for Crohn's Disease in the opinion of and as documented by the treating physician.
3. Harvey Bradshaw Index score >= 7.
4. Males and females >=18 and <=75 years of age at the Baseline visit.
5. Negative pregnancy test.
6. Use of reliable contraception.
7. Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol.
8. Adequate cardiac, renal and hepatic function as determined by the principal investigator and demonstrated by Screening laboratory evaluations, questionnaires, and physical examination results that are within normal limits.
9. Subjects must be able to self-inject study medication or have a designee or healthcare professional who can inject the study medication.
Exclusion criteria
1. History of cancer or lymphoproliferative disease other than a successfully and completely treated cutaneous squamous cell or basal cell carcinoma or carcinoma * in-situ of the cervix.
2. History of listeria, human immunodeficiency virus (HIV), chronic or active Hepatitis B, an immunodeficiency syndrome, central nervous system (CNS), demyelinating disease or active tuberculosis (TB).
3. Subjects with abscess or suspicion of abscess.
4. Subject who has had surgical bowel resections within the past 6 months or is planning any resection at any time point while enrolled in the study.
5. Females who are pregnant or will not discontinue breast-feeding.
6. Subject who has an active infection or has had systemic antibiotic, antiviral, or antifungal treatment within 3 weeks prior to Baseline for infection. Subjects are allowed to be on ciprofloxacin or metronidazole for their non-infectious Crohn's symptoms.
7. Subject with a history of clinically significant drug or alcohol abuse in the last year.
8. Subjects with a poorly controlled medical condition.
9. Subjects with positive C. difficile stool assay.
10. Previous treatment with adalimumab or previous participation in an adalimumab clinical study.
11. Abnormal, clinically significant screening laboratory and other analyses (including ECG).
12. Subjects with any prior exposure to Tysabri® (natalizumab).
13. Subjects on prednisone >40 mg/day (or equivalent), subjects on budesonide >9 mg/day, or subjects who are taking prednisone and budesonide concurrently at Baseline.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-002078-23-NL |
| CCMO | NL13963.075.06 |