Can PET scan be used to assess disease activity in patients with sarcoidosis during treatment with adalimumab (Humira)? - KOMPLET

Phase 1

• Conditions: sarcoidosis

• Registration Number: EUCTR2006-001816-56-DK
• Lead Sponsor: Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-28
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

A person may participate in this trial if he/she fulfils the following criteria:
- Patients (>= 18 years) with verified biopsy of sarcoidosis according to The Joint Statement of the American Thoracic Society (ATS), the European Respiratory Society (ERS) and the World Association of Sarcoidosis (WASOG) criteria.
- Clinically and/or biochemical disease activity in one or more organ systems defined as decreased lung function (FEV1 <70% of expected value and/or DLCO <70% of expected value; hypercalcaemia; impact on liver (elevated alkaline phosphatase and bilirubin and/or aspartate aminotranferase.
- Previous treatment with prednisolon tablets 5-10 mg/week for at least 6 months with inadequate clinical and/or biochemical response as judged by Investigator.
- Pathological increased FDG uptake on PET imaging corresponding to at least one known focus at first FDG PET scan.
- Negative pregnancy test (serum HCG) for women of childbearing potential prior to trial start. (Non-fertile women defined as postmenopausal for at least 1 year or surgical sterilisation (bilateral tubal ligation, bilateral ooforectomy or hystorectomy)). Fertile women included in the trial should use contraceptives during the entire trial period (i.e. one of the following methods: Oral contraceptives, intrauterine device (IUD), depot injection of progesterone, subdermal implantation, contraceptive vaginal ring, transdermal depot plaster). Contraceptives should also be used for a period of 150 days after any discontinuation of trial medicine.
- Ability and willingness to inject the s.c. injections him/herself or to have a person available for giving the injections.
- Ability and willingness to give written informed consent and meet the requirements in the trial protocol.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A person may not participate in this trial, if he/she fulfils one or more of the following criteria:
- Positive serology for Hepatitis B or C indicating active infection.
- Medical history with positive HIV status.
- Medical history with tuberculosis, histoplasmosis or listeriosis.
- Persons with latent TB (positive Mantoux skin-test, positive Quantiferon-Gold test, positive inoculation of mycobacterium in tissue samples and/or chest x-ray indicating TB) or other risk factors for activating latent TB.
- Active or recurrent infections or severe infections requiring hospitalization or treatment with i.v. antibiotics within the last 30 days or oral antibiotics within the last 14 days prior to inclusion.
- Previous cancer or lymph proliferative disease except from completely well treated squamous cell carcinoma, basal cell carcinoma or cervix dysplasia.
- Diabetes, unstable ischemic heart disease, heart insufficiency (NYHA III-IV), active chronic inflammatory intestinal disease, recent cerebral apoplexia (within 3 months), chronic leg ulcus or any other condition (e.g. catheter à demeure) imposing an increased risk to the subject, if he/she participates in the protocol, as judged by Investigator.
- Pregnancy or breast-feeding.
- Clinically significant drug or alcohol abuse during the last year.
- Previous diagnosis or signs of demyelinized disease in the CNS system (e.g. optic neuritis, visual disorder, difficulty in walking/ataxia, facial paresis, apraxia).
- No pathological increased FDG PET imaging at first FDG PET scan.

Study & Design

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