Symptoms and General Pathology

All Conditions

Blood and Lymph Conditions

Immune System Diseases

Necrosis

Sarcoidosis

Lymphoproliferative Disorders

Lymphatic Diseases

Hypersensitivity

Hypersensitivity, Delayed

Anti-Inflammatory Agents

All Drugs and Chemicals

Antirheumatic Agents

Tumor Necrosis Factor Inhibitors

Adalimumab

Patients received adalimumab 40 mg weekly for 45 weeks, with a final follow-up at Week 52

Subjects will give themselves a dose of Adalimumab at 40 mg/every week by subcutaneous injection for a total of 45 weeks.

Nadera J. Sweiss, M.D.

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.

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.

Trial of Adalimumab in Progressive Sarcoidosis

A Prospective Open-Label Trial of Adalimumab in Progressive Sarcoidosis

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.

This is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes

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.

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.

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.

Abbott

University of Chicago

Patients received adalimumab 40 mg weekly for 45 weeks, with a final follow-up at Week 52

Adalimumab: Subjects will give themselves a dose of Adalimumab at 40 mg/every week by subcutaneous injection for a total of 45 weeks.

There were no adverse events.

An Open-label

Patients received adalimumab 40 mg weekly for 45 weeks, with a final follow-up at Week 52

Adalimumab: Subjects will give themselves a dose of Adalimumab at 40 mg/every week by subcutaneous injection for a total of 45 weeks.

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

The population is male and female between the ages of 18-65

Nadera J Sweiss

Participant 1

Participant 2

Participant 3

Participant 4

Participant 5

Participant 6

Participant 7

Participant 8

Participant 9

Participant 10

Participant 11

Change in FVC From Screening to Week 24

Change in Distance Walked During 6 Minute Walk Test at Screening and 24 Weeks

This scale was used to measure a patients breathlessness before/after the 6 Minute Walk at Screening and at 24 weeks.

Borg Dyspnea Scores

A Change in the Borg Dyspnea Score Before/After the 6 Minute Walk at Screening (S) and at 24 Weeks (W).

Physicians Global Assessment

Physicians Global Assessment of Disease Activity.

Patients Global Assessment

Patient's Global Assessment of Disease Activity.

Overall Study

Skin and Connective Tissue Diseases

Psoriasis

Skin Diseases

Skin Diseases, Papulosquamous

Dermatologic Agents

Amino Acids

Deucravacitinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Deucravacitinib 6mg oral intake once daily for 4 weeks

Matching Placebo oral intake once daily for 4 weeks

Franziska Stuber, RN

Curdin Conrad, Professor

Paradoxical psoriasis is a side effect of a biological treatment (anti-tumor necrosis factor agent, short called anti-TNF) that is used to treat diseases of the skin, the intestine or the joints. If paradoxical psoriasis occurs, the anti-TNF-treatment often needs to be stopped and so far, no specific treatment for paradoxical psoriasis exists.

This research project aims to study whether the efficacy of the drug 'Deucravacitinib' 6mg, a tablet taken by mouth once a day is superior compared to taking a placebo in treating paradoxical psoriasis.

During 4 weeks the patients of the 2 arms receive either Deucravacitinib 6mg 1x/day or an identically looking placebo.

At Week 4, Patients with underlying disease of Crohn's disease, colitis ulcerosa, uveitis will stop the study, to avoid that they are too long without efficient treatment for their underlying disease.

Patients with underlying disease of psoriasis or psoriatic arthritis will have the possiblity to continue in Part 2, where they all will receive Deucravacitinib 6mg 1x/day, open label for 3 months

TYK2 Inhibition in Paradoxical Psoriasis

Tyrosine Kinase 2 (TYK2) Inhibition in Paradoxical Psoriasis A Randomized, Double-blind, Placebo-controlled Multi-center Study Evaluating the Effect of Deucravacitinib on Severity of Psoriasis in Patients With Paradoxical Psoriasis

Normalization of inflammatory gene signature

Percentage of patients attaining PxP IGA 0/1 and at least a reduction of 2 points from baseline

Change of Paradoxical Psoriasis Body Surface Area ( PxP-BSA )

Change of Paradoxical Psoriasis palmoplantar Psoriasis Area and Severity Index (PxP PPPASI) Score in patients presenting paradoxical psoriasis of the hands of feet

Change of Paradoxical Psoriasis Scalp Investigator General Assessment (PxP-scalp IGA) if paradoxical Psoriasis is affecting the Scalp

Change of Psoriasis Area and Severity Index (PASI) in patients with pre-existing disease of Psoriasis

Percentage of patients with underlying disease of psoriasic arthritis, having an American College of Rheumatology (ACR) Score of 20%, 50% or 70% reduction in comparion with the Baseline assessment.

Centre Hospitalier Universitaire Vaudois

Prof Curdin Conrad

Associate Professor

Musculoskeletal Diseases

Arthritis

Arthritis, Rheumatoid

Joint Diseases

Rheumatic Diseases

Collagen Diseases

Connective Tissue Diseases

Autoimmune Diseases

Antineoplastic Agents

Abatacept

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Immunosuppressive Agents

Immunologic Factors

TNFi claim is used as the reference group.

Abatacept claim is used as the exposure group.

Rishi J Desai, PhD

Madhav Thambisetty, MD, PhD

This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication.

This is a non-randomized, non-interventional study that is part of the DREAM Study of Brigham and Women's Hospital. DREAM is led by Dr. Madhav Thambisetty, MD, PhD, Chief of the Clinical and Translational Neuroscience Section, Laboratory of Behavioral Neuroscience, National Institute on Aging (NIA) intramural research program. This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication using healthcare claims data.

Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - TNFi vs Abatacept

Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines - Tumor Necrosis Factor Inhibitors vs Abatacept

Time to dementia onset, i.e., Alzheimer's disease, vascular dementia, senile, presenile, or unspecified dementia, or dementia in other diseases classified elsewhere. Please refer to uploaded protocol for full definition due to size limitations.

Time to Alzheimer's disease onset. Please refer to uploaded protocol for full definition due to size limitations.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial of Adalimumab in Progressive Sarcoidosis	NCT00311246	Sarcoidosis	Adalimumab	18 Years - 85 Years	University of Chicago
TYK2 Inhibition in Paradoxical Psoriasis	NCT06281106	Psoriasis	Deucravacitinib	18 Years -	Centre Hospitalier Universitaire Vaudois
Trial of Adalimumab in Progressive Sarcoidosis	NCT00311246	Sarcoidosis	Adalimumab	18 Years - 85 Years	University of Chicago
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - TNFi vs Abatacept	NCT04529902	Rheumatoid Arth...	Tumor Necrosis ... Abatacept	18 Years -	Brigham and Women's Hospital
TYK2 Inhibition in Paradoxical Psoriasis	NCT06281106	Psoriasis	Deucravacitinib	18 Years -	Centre Hospitalier Universitaire Vaudois

Spots Global Cancer Trial Database for tumor necrosis factor inhibitors