Trial of Adalimumab in Progressive Sarcoidosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00311246
• Date of registration: 03/04/2006
• Prospective Registration: No
• Primary sponsor: University of Chicago
• Public title: Trial of Adalimumab in Progressive Sarcoidosis
• Scientific title: A Prospective Open-Label Trial of Adalimumab in Progressive Sarcoidosis
• Date of first enrolment: April 2006
• Target sample size: 11
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00311246
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Nadera J. Sweiss, M.D.
• Affiliation: The University of Chicago Hospitals

Key inclusion & exclusion criteria

Inclusion Criteria:

- Men and women > 18 years of age.

- Sarcoidosis diagnosed at least 1 year prior to screening.

- Histologically proven sarcoidosis prior to screening.

- Have a diagnosis of sarcoidosis with evidence of parenchymal disease on chest
radiograph (Stage II or III) or Stage I disease by chest radiographs and evidence of
abnormal PFT as below or normal chest radiograph; or abnormal PFT, with abnormal chest
computed tomography (CT) and evidence of sarcoid lung involvement by histology.
Subjects with concurrent extrapulmonary sarcoidosis, particularly skin and eye
involvement, are encouraged to be enrolled.

- Have forced vital capacity (FVC) > 40 and < 80% of predicted.

- Have an American Thoracic Society (ATS) dyspnea score of > Grade 1.

- Have been receiving pre-study treatment that includes at least 10 mg/day prednisone
(or equivalent dose of corticosteroid) as a single agent, or 1 or more
immunosuppressant (e.g., methotrexate, azathioprine, cyclophosphamide, chloroquine,
leflunomide, hydroxychloroquine, mycophenolate mofetil, cyclosporine, tacrolimus,
corticosteroids) for at least the 3-month period immediately prior to screening.
Subjects must be on a stable dose of these medications for > 4 weeks before starting
the study medication.

- Adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine
device, barrier method with spermicide, or surgical sterilization) must be used for
the duration of the study and such precautions should be continued for 6 months after
receiving the last study agent injection.

- Are considered eligible based on TB screening

Exclusion Criteria:

- Have used any investigational drug within 1 month prior to screening.

- Have received previous administration of a treatment with any other therapeutic agent
targeted at reducing tumor necrosis factor [TNF] (e.g., pentoxifylline, thalidomide,
etanercept, infliximab) within 3 months prior to screening.

- Have received previous administration of adalimumab.

- Have received any live virus or bacterial vaccinations within the 3 months before the
first dose of the study agent or are expected to receive any live virus or bacterial
vaccinations during the trial or up to 3 months after the last dose of the study
agent.

- Have had any previous adverse reactions or allergic reactions (e.g., anaphylaxis)
associated with the administration of monoclonal antibodies.

- Have New York Heart Association (NYHA) Class III or IV congestive heart failure (CHF).

- Have a history of severe right-sided heart failure or cor pulmonale.

- Have had serious infections within 2 months of screening. Less serious infections
(such as acute upper respiratory tract infection [colds] or a simple urinary tract
infection) need not be considered as exclusion at the discretion of the investigator.

- Are considered ineligible according to the United States of America (USA)-specific TB
screening.

- Have or have had an opportunistic infection (e.g., herpes zoster [shingles],
cytomegalovirus, Pneumocystis carinii, aspergillosis and aspergilloma, histoplasmosis,
or mycobacteria other than TB) within 6 months prior to screening.

- Have a known infection with human immunodeficiency virus (HIV).

- Have current signs and symptoms of systemic lupus erythematosus, or severe,
progressive, or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary,
cardiac, neurologic, or cerebral diseases (with the exception of sarcoidosis).

- Presence of a transplanted organ (with the exception of a corneal transplant) > 3
months prior to screening.

- Have any known malignancy or history of malignancy within 5 years prior to screening.

- Have a history of lymphoproliferative disease including lymphoma, or signs and
symptoms suggestive of possible lymphoproliferative disease.

- Are pregnant, nursing, or planning pregnancy (both men and women) during the trial or
within the 6-month period thereafter.

- Have had a known substance abuse or dependency, drug or alcohol within 3 years of
screening.

- Have poor tolerability of subcutaneous injection or lack of adequate venous access for
required blood sampling.

- Have a known history of demyelinating disease such as multiple sclerosis or optic
neuritis.

- Presence of a non-sarcoidosis condition affecting survival.

- Have mental health problems interfering with participation.



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Sarcoidosis

Intervention(s)

Drug: Adalimumab

Primary Outcome(s)

Change in FVC From Screening to Week 24 [Time Frame: 24 Weeks]

Secondary Outcome(s)

A Change in the Borg Dyspnea Score Before/After the 6 Minute Walk at Screening (S) and at 24 Weeks (W). [Time Frame: 24 weeks]

Physicians Global Assessment of Disease Activity. [Time Frame: 24 weeks]

Change in Distance Walked During 6 Minute Walk Test at Screening and 24 Weeks [Time Frame: 24 weeks]

Patient's Global Assessment of Disease Activity. [Time Frame: 24 weeks]

Secondary ID(s)

University of Chicago #14093A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Abbott

Results

• Results available: Yes
• Date Posted: 14/08/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00311246