SarcoidosisPhase 2NCT00311246
Trial of Adalimumab in Progressive Sarcoidosis
A Phase 2 study testing Adalimumab in people with Sarcoidosis, run by University of Chicago at 1 site in United States.
Trial summary
Sarcoidosis is a rare disease that can affect any organ in the body. It is characterized by the buildup of immune-system (fights off infection in the body) cells in organs. These cells form small groups called granulomas, which lead to inflammation of the surrounding tissue. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sarcoidosis
- What is being tested?
- Adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Sep 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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
Who cannot join
- 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).
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Open-Label Trial of Adalimumab in Progressive Sarcoidosis
Sarcoidosis is a rare disease that can affect any organ in the body. It is characterized by the buildup of immune-system (fights off infection in the body) cells in organs. These cells form small groups called granulomas, which lead to inflammation of the surrounding tissue. Sarcoidosis most commonly affects the lung and the lymph nodes (part of the immune system). The signs usually include shortness of breath, fever, dry cough, and chest pain. Other signs in many patients can include redness and painful lumps on the skin, reduced eyesight, joint pain, and rarely, nervous system damage. Sarcoidosis commonly affects young and middle-aged adults.
There are no approved therapies for the treatment of sarcoidosis. Corticosteroid (steroid hormone) therapy is considered the standard treatment. Only limited benefit has been shown when using corticosteroid therapy to ease lung symptoms or improve lung function in patients with sarcoidosis. Also, the effects of other therapies (for example: methotrexate, cyclophosphamide, anti-malarial drugs, thalidomide) and other immunosuppressants (drugs that suppress a body's natural defense system [immune system]) which have been used in a small number of patients are not well known and can cause long term problems.
The drug used in this study is called adalimumab. Adalimumab is FDA (Food and Drug Administration) approved for patients with moderately to severely active rheumatoid arthritis. However, adalimumab is not approved for the treatment of sarcoidosis. Adalimumab is experimental in this study. The purpose of this study is to evaluate the safety and effectiveness of adalimumab in the treatment of patients with sarcoidosis with pulmonary (lung) involvement who show symptoms of the disease even though they are currently being treated with medication.
Read the detailed description
This study consists of 11 visits (including screening).
Screening Procedures:
A chest radiograph (PA and lateral) must be obtained within 3 months prior to the first study injection. It must indicate that subject is free of tuberculosis (TB). The chest radiograph will also be used to confirm the stage of the disease.
Histologically proven sarcoidosis will be confirmed.
Demographic data, a complete medical history (including signs and symptoms of sarcoidosis), a physical examination (including vital signs, weight and height). The medical history will include questions about history of recent TB and history of close contact with persons who might have TB. Concomitant medications, including the use of oral corticosteroids and immunosuppressants, will be reviewed and recorded. In addition the inclusion and exclusion criteria will be reviewed.
A tuberculin skin test will be performed.
A serum pregnancy test will be performed for all women within the 4-week period prior to the Baseline (Week 0) Visit. All women must test negative for pregnancy at screening.
ATS dyspnea score will be assessed.
The 6-minute walk test will be performed with Borg's CR10 dyspnea score obtained before and after.
Pulmonary function tests [PFTs] (spirometry) will be performed.
Blood samples for routine laboratory analyses will be obtained.
AE monitoring will also be performed.
Subjects who qualify for the study should be assigned to receive treatment within 14 days of the screening visit except if additional time is required for repeat TB skin testing.
Patients should still meet all of the inclusion criteria and none of the exclusion criteria at the time of the baseline visit before starting the injections. Subjects must agree to use appropriate contraception.
The procedures involved at all study visits are described below.
- Informed Consent: (Screening Visit): Subjects will be asked to review this consent form and discuss with the study doctor or study staff any questions they may have
- Health and Medication Questions: (Screen, Weeks 0, 2, 6, 12, 24, 30, 36, 45, 52): Subjects will be asked to answer questions about their health, their medical history, and the medications they take.
- Physical Exam: (Screen, Weeks 6, 24, 52): Do a physical exam.
- Vital Signs: (Screen, Weeks 0, 6, 12, 24, 52): Blood Pressure, Pulse, Temperature
- Height and Weight: (Screen, Week 52)
- Blood Tests: (Screen, Weeks 12, 24, 45, 52): Approximately 3 teaspoons of blood will be drawn from a vein in subject's hand or arm for these tests.
- Lung Function Test: (Screen, Weeks 24, 52): Subject will be given a mouthpiece and asked to take deep breaths into a machine connected to a computer according to the cues of a staff member. The machine will measure the capacity of subject's lungs.
- Chest X-ray: (Screen, Weeks 12, 24, 52):
- Tuberculosis Test: (Screen only): Subject will be asked specific questions regarding their history of tuberculosis (also called TB: a type of bacterial lung infection) or personal contact with people with active tuberculosis. Subjects with active tuberculosis cannot be in the study. Subjects will be given a skin test for tuberculosis. For all subjects in this trial, a TB skin test with negative results must be obtained.
- 6 Minute Walk Test: (Screen, Weeks 0, 12, 24, 52): Subject will be asked to complete a test where they will walk for 6 minutes. Subject will be asked specific questions regarding any shortness of breath they have.
- Pregnancy Test: (Screen only): A pregnancy blood test will be performed on all women of childbearing potential at the screening visit. The results of the test must be negative in order for subject to participate in the study.
- ECG: (Week 0 only)
- Study Drug Administration: (Weeks 0, 2, 6, 12, 18, 24, 30, 36, 45): Subject will receive study drug at the Week 0 Visit and be taught how to give themselves injections. Subject will be given a supply of study drug and clinical supplies that will last until the next study visit. Subject will be required to return all unused study drug as well as the packaging for the used study drug at each visit.
- Questionnaires: (Weeks 0, 2, 12, 18, 24, 30, 36, 45): Prior to receiving any study drug, subject will be asked questions about their symptoms and quality of life, including their ability to care for themselves and carry out normal everyday activities (respiratory and health surveys) and health questionnaires.
All subjects will return for efficacy and safety evaluations at each time point including week 52, whether or not they complete the entire treatment schedule and whether or not they are (still) responding to treatment.
We will watch carefully for signs and symptoms of CHF and active TB at follow-up evaluations for all patients. The study agent will be stopped in subjects who are found to have NYHA Class III or IV CHF, severe right-sided heart failure, cor pulmonale, and/or active TB after enrollment in the study but they must return for further follow-up evaluations.
- Conditions
- Sarcoidosis
- Being tested
- Adalimumab
- Keywords
- Sarcoidosis, Humira, Adalimumab, Tumor Necrosis Factor Inhibitors
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
Also called Humira
Subjects will give themselves a dose of Adalimumab at 40 mg/every week by subcutaneous injection for a total of 45 weeks.
| Study group | Role | What they receive |
|---|---|---|
| An open-label | Experimental | Patients received adalimumab 40 mg weekly for 45 weeks, with a final follow-up at Week 52 Receives: Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FVC From Screening to Week 24
The forced vital capacity (FVC) measurement shows the amount of air a person can forcefully and quickly exhale after taking a deep breath. Improvement in FVC, if significant, means better breathing and lung function. The change in FVC done at screening and at week 24 were compared to notice if there were any changes.
Measured: 24 Weeks
Secondary outcomes (4)
Change in Distance Walked During 6 Minute Walk Test at Screening and 24 Weeks
This is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes
Measured: 24 weeks
A Change in the Borg Dyspnea Score Before/After the 6 Minute Walk at Screening (S) and at 24 Weeks (W).
This scale was used to measure a patients breathlessness before/after the 6 Minute Walk. This score was used at Screening (S) and at 24 weeks (W). The borg scale ranges from zero to 10 with zero being no breathlessness at all and 10 being maximal breathlessness. A change between screening and week 24 is reported.
Measured: 24 weeks
Physicians Global Assessment of Disease Activity.
This assessment to determine the level of disease activity. Scores range from 0 (no pulmonary manifestations of sarcoidosis) to 100 (worsening of pulmonary symptoms) on a visual analog scale.
Measured: 24 weeks
Patient's Global Assessment of Disease Activity.
This is the patients measurement of disease activity. Scores range from 0 (no pulmonary manifestations of sarcoidosis) to 100 (worsening of pulmonary symptoms) on a visual analog scale.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionMay 2008
- Study completionSep 2008
Why it stopped: Difficulty in recruiting subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Nadera J. Sweiss, M.D., Principal investigator, The University of Chicago Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311246
- Sponsor's protocol ID
- University of Chicago #14093A
- Status last verified
- Mar 2020
- First submitted
- 3 Apr 2006
- Last updated
- 25 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Sweiss NJ, Noth I, Mirsaeidi M, Zhang W, Naureckas ET, Hogarth DK, Strek M, Caligiuri P, Machado RF, Niewold TB, Garcia JG, Pangan AL, Baughman RP. Efficacy Results of a 52-week Trial of Adalimumab in the Treatment of Refractory Sarcoidosis. Sarcoidosis Vasc Diffuse Lung Dis. 2014 Apr 18;31(1):46-54.
PubMed 24751453
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Open-Label Trial of Adalimumab in Progressive Sarcoidosis
- ClinicalTrials.gov ID
- NCT00311246
- Acronym / sponsor ID
- University of Chicago #14093A
- Conditions
- Sarcoidosis
- Keywords
- Sarcoidosis, Humira, Adalimumab, Tumor Necrosis Factor Inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruiting subjects
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Apr 2006
- Primary completion
- May 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 5 Apr 2006 (estimated)
- Results
- Posted 14 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sarcoidosis is a rare disease that can affect any organ in the body. It is characterized by the buildup of immune-system (fights off infection in the body) cells in organs. These cells form small groups called granulomas, which lead to inflammation of the surrounding tissue. Sarcoidosis most commonly affects the lung and the lymph nodes (part of the immune system). The signs usually include shortness of breath, fever, dry cough, and chest pain. Other signs in many patients can include redness and painful lumps on the skin, reduced eyesight, joint pain, and rarely, nervous system damage. Sarcoidosis commonly affects young and middle-aged adults.
There are no approved therapies for the treatment of sarcoidosis. Corticosteroid (steroid hormone) therapy is considered the standard treatment. Only limited benefit has been shown when using corticosteroid therapy to ease lung symptoms or improve lung function in patients with sarcoidosis. Also, the effects of other therapies (for example: methotrexate, cyclophosphamide, anti-malarial drugs, thalidomide) and other immunosuppressants (drugs that suppress a body's natural defense system [immune system]) which have been used in a small number of patients are not well known and can cause long term problems.
The drug used in this study is called adalimumab. Adalimumab is FDA (Food and Drug Administration) approved for patients with moderately to severely active rheumatoid arthritis. However, adalimumab is not approved for the treatment of sarcoidosis. Adalimumab is experimental in this study. The purpose of this study is to evaluate the safety and effectiveness of adalimumab in the treatment of patients with sarcoidosis with pulmonary (lung) involvement who show symptoms of the disease even though they are currently being treated with medication.
Detailed description
This study consists of 11 visits (including screening).
Screening Procedures:
A chest radiograph (PA and lateral) must be obtained within 3 months prior to the first study injection. It must indicate that subject is free of tuberculosis (TB). The chest radiograph will also be used to confirm the stage of the disease.
Histologically proven sarcoidosis will be confirmed.
Demographic data, a complete medical history (including signs and symptoms of sarcoidosis), a physical examination (including vital signs, weight and height). The medical history will include questions about history of recent TB and history of close contact with persons who might have TB. Concomitant medications, including the use of oral corticosteroids and immunosuppressants, will be reviewed and recorded. In addition the inclusion and exclusion criteria will be reviewed.
A tuberculin skin test will be performed.
A serum pregnancy test will be performed for all women within the 4-week period prior to the Baseline (Week 0) Visit. All women must test negative for pregnancy at screening.
ATS dyspnea score will be assessed.
The 6-minute walk test will be performed with Borg's CR10 dyspnea score obtained before and after.
Pulmonary function tests [PFTs] (spirometry) will be performed.
Blood samples for routine laboratory analyses will be obtained.
AE monitoring will also be performed.
Subjects who qualify for the study should be assigned to receive treatment within 14 days of the screening visit except if additional time is required for repeat TB skin testing.
Patients should still meet all of the inclusion criteria and none of the exclusion criteria at the time of the baseline visit before starting the injections. Subjects must agree to use appropriate contraception.
The procedures involved at all study visits are described below.
- Informed Consent: (Screening Visit): Subjects will be asked to review this consent form and discuss with the study doctor or study staff any questions they may have
- Health and Medication Questions: (Screen, Weeks 0, 2, 6, 12, 24, 30, 36, 45, 52): Subjects will be asked to answer questions about their health, their medical history, and the medications they take.
- Physical Exam: (Screen, Weeks 6, 24, 52): Do a physical exam.
- Vital Signs: (Screen, Weeks 0, 6, 12, 24, 52): Blood Pressure, Pulse, Temperature
- Height and Weight: (Screen, Week 52)
- Blood Tests: (Screen, Weeks 12, 24, 45, 52): Approximately 3 teaspoons of blood will be drawn from a vein in subject's hand or arm for these tests.
- Lung Function Test: (Screen, Weeks 24, 52): Subject will be given a mouthpiece and asked to take deep breaths into a machine connected to a computer according to the cues of a staff member. The machine will measure the capacity of subject's lungs.
- Chest X-ray: (Screen, Weeks 12, 24, 52):
- Tuberculosis Test: (Screen only): Subject will be asked specific questions regarding their history of tuberculosis (also called TB: a type of bacterial lung infection) or personal contact with people with active tuberculosis. Subjects with active tuberculosis cannot be in the study. Subjects will be given a skin test for tuberculosis. For all subjects in this trial, a TB skin test with negative results must be obtained.
- 6 Minute Walk Test: (Screen, Weeks 0, 12, 24, 52): Subject will be asked to complete a test where they will walk for 6 minutes. Subject will be asked specific questions regarding any shortness of breath they have.
- Pregnancy Test: (Screen only): A pregnancy blood test will be performed on all women of childbearing potential at the screening visit. The results of the test must be negative in order for subject to participate in the study.
- ECG: (Week 0 only)
- Study Drug Administration: (Weeks 0, 2, 6, 12, 18, 24, 30, 36, 45): Subject will receive study drug at the Week 0 Visit and be taught how to give themselves injections. Subject will be given a supply of study drug and clinical supplies that will last until the next study visit. Subject will be required to return all unused study drug as well as the packaging for the used study drug at each visit.
- Questionnaires: (Weeks 0, 2, 12, 18, 24, 30, 36, 45): Prior to receiving any study drug, subject will be asked questions about their symptoms and quality of life, including their ability to care for themselves and carry out normal everyday activities (respiratory and health surveys) and health questionnaires.
All subjects will return for efficacy and safety evaluations at each time point including week 52, whether or not they complete the entire treatment schedule and whether or not they are (still) responding to treatment.
We will watch carefully for signs and symptoms of CHF and active TB at follow-up evaluations for all patients. The study agent will be stopped in subjects who are found to have NYHA Class III or IV CHF, severe right-sided heart failure, cor pulmonale, and/or active TB after enrollment in the study but they must return for further follow-up evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| An open-label | Experimental | Drug: AdalimumabPatients received adalimumab 40 mg weekly for 45 weeks, with a final follow-up at Week 52 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdalimumabAlso: HumiraSubjects will give themselves a dose of Adalimumab at 40 mg/every week by subcutaneous injection for a total of 45 weeks. | Drug | An open-label |
Primary outcome
Change in FVC From Screening to Week 24
Time frame: 24 Weeks
The forced vital capacity (FVC) measurement shows the amount of air a person can forcefully and quickly exhale after taking a deep breath. Improvement in FVC, if significant, means better breathing and lung function. The change in FVC done at screening and at week 24 were compared to notice if there were any changes.
4 secondary outcomes
Change in Distance Walked During 6 Minute Walk Test at Screening and 24 Weeks
Time frame: 24 weeks
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
Patient's Global Assessment of Disease Activity.
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24751453Sweiss NJ, Noth I, Mirsaeidi M, Zhang W, Naureckas ET, Hogarth DK, Strek M, Caligiuri P, Machado RF, Niewold TB, Garcia JG, Pangan AL, Baughman RP. Efficacy Results of a 52-week Trial of Adalimumab in the Treatment of Refractory Sarcoidosis. Sarcoidosis Vasc Diffuse Lung Dis. 2014 Apr 18;31(1):46-54.
- Efficacy Results of a 52-week Trial of Adalimumab in the Treatment of Refractory Sarcoidosis.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadera J. Sweiss, M.D. principal investigator
The University of Chicago Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adalimumab in people with Sarcoidosis, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FVC From Screening to Week 24 (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00311246, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2020.