Studies That Have Completed Recruitment
Trials that are no longer recruiting but remain active to complete other study activities are found here. Click on a disease/condition below to learn more about a range of clinical trials studying new and existing interventions for prevention and treatment of arthritis, musculoskeletal and skin diseases.
Please check other clinical trials supported by the NIAMS that are actively recruiting or have completed with published results following the links below.
View Actively Recruiting Studies
View Completed Studies with Published Results
For questions, please contact the NIAMS Clinical Trials team at: [email protected]
Disease / Condition
- Atopic Dermatitis
- Chronic Low Back Pain
- Fibromyalgia
- Granulomatosis with Polyangiitis (GPA)
- Hand Osteoarthritis
- Knee Osteoarthritis
- Knee Replacement
- Meniscal tear and Osteoarthritis (OA)
- Pompe Disease
- Systemic Lupus Erythematosus (SLE)
Atopic Dermatitis
JAK Inhibition in Down Syndrome
People with Down syndrome (DS) display profound immune dysregulation, which could have myriad negative impacts on their health, including the development of various immune and neurological disorders. Multiple lines of evidence indicate that hyperactivation of interferon (IFN) signaling drives immune dysregulation in DS. This study aims to complete a clinical trial in adults with DS and immune skin conditions, using a pharmacological inhibitor of IFN signaling, which is expected to have multidimensional therapeutic benefits in this population.
View more about this trial in Clinical Trials.gov
Team-Based Connected Health to Improve Access and Outcomes in Atopic Dermatitis
Skin diseases account for 30% of all physician office visits. In the United States, access to dermatologists remains a significant challenge for those in underserved or rural communities. To increase access to specialists and improve patient outcomes, this study will evaluate a team-based connected health (TCH) model that enables structured asynchronous online interactions among patients, primary care providers (PCPs), and dermatologists. The goal of TCH is to enable effective management of chronic skin diseases via high-quality and efficient online care between providers and patients. TCH purports to bring direct and expedient specialist care to patients and PCPs in a location-independent and asynchronous manner. Specifically, TCH offers several ways that patients and providers can communicate online asynchronously to manage skin diseases: (1) PCP-dermatologist, (2) patient-dermatologist, and (3) patient-PCP interactions. With PCP-dermatologist interactions, PCPs can access dermatologists online asynchronously for consultations or to request a dermatologist to assume care of patient’s skin disease. With patient-dermatologist interactions, patients can upload clinical images and history online and obtain asynchronous evaluation and recommendations from dermatologists directly. Finally, PCPs have the option of managing their patients’ skin diseases online. Importantly, TCH applies efficient workflow that maximally supports providers and fosters multi-directional, informed communication among patients, PCPs, and dermatologists.
View more about this trail in ClinicalTrials.gov
A Community-based Assessment of Skin Care, Allergies, and Eczema: The CASCADE Trial
Atopic dermatitis (AD) affects over 9 million children in the U.S. and often heralds the development of asthma, food allergy, skin infections and neurodevelopmental disorders. Recent advances identify skin barrier dysfunction to be the key initiator of AD and possibly allergic sensitization.
This study hypothesizes that daily emollient use from birth can prevent the development of AD in a community setting and into newborns unselected for risk. The results of a community-based clinical trial utilizing a pragmatic trial design will be immediately applicable to the population at large and will establish a new standard of care for all newborns.
View more about this trial in ClinicalTrials.gov
Chronic Low Back Pain
Proof of Concept Study to Treat Negative Affect in Chronic Low Back Pain
This study addresses the need for better evidence-based pain treatment for patients with chronic low back pain (CLBP) who have co-occurring negative affective disorders, such as major depression with anxious features. The CLBP subgroup with comorbid depression or anxiety disorders (commonly termed, high negative affect) is approximately 20-30% of the 50 million adults with CLBP in the United States. This subgroup is particularly refractory to pain treatment and is in desperate need of better non-opioid, comprehensive pain treatment options. Patients with CLBP and high levels of negative affect (NA) suffer higher levels of pain and have worse disability and function. Due to these factors, they have been prescribed opioids more frequently and misuse opioids at a much greater rate (40-60% rates of non-adherence), which is related to self-medication of depression and anxiety by taking extra opioids. Poor pain management in patients with high NA is due in part to a lack of more effective evidence-based treatment options to improve pain, depression, anxiety, and function, and prevent opioid misuse.
View more about this trial in ClinicalTrials.gov
University of Michigan BACPAC Mechanistic Research Center
For the NIH BACPAC initiative, this study proposes a single Research Project that will take patients with chronic lower back pain (cLBP) and use a patient-centric, Sequential Multiple Assessment Randomized Trial (SMART) design study to follow these individuals longitudinally as they try several different evidence-based therapies, while mechanistic studies are overlaid to draw crucial inferences about what treatments will work in what patient endotypes. The study uses the term Interventional Response Phenotyping to describe the need in any precision medicine initiative to phenotype participants regarding what therapies they do and do not respond to - so that one can later link mechanistically distinct disease endophenotypes with those who preferentially respond to therapies targeting those mechanisms.
View more about this trial in ClinicalTrials.govFibromyalgia
Fibromyalgia TENS in Physical Therapy Study (FM-TIPS) (FM-TIPS)
Fibromyalgia (FM) is a chronic pain condition characterized by widespread musculoskeletal pain, tenderness, and stiffness associated with fatigue and sleep disturbance. The goal of reducing opioid use in patients with chronic pain requires that proven non-pharmacological treatments are applied in clinical practice. The study team has recently completed the FAST (Fibromyalgia Activity Study with TENS) trial demonstrating the efficacy of Active Transcutaneous Electrical Nerve Stimulation (TENS) compared with Placebo TENS or No Treatment in women with FM. While physical therapists are trained in the use of TENS, it is underused in clinical practice. This study proposes to conduct an embedded pragmatic trial to compare the effectiveness of physical therapy with or without the addition of TENS for FM patients within physical therapy (PT) practices as the study sites.
View more about this trial in ClinicalTrials.gov
Granulomatosis with Polyangiitis (GPA)
The Assessment of Prednisone In Remission Trial (TAPIR) - Patient Centric Approach
Granulomatosis with polyangiitis (Wegener’s) (GPA) is a primary systemic vasculitis, predominantly involving microscopic blood vessels with no or scanty immune deposits. GPA is strongly associated with circulating auto-antibodies to neutrophils (ANCA) and is one of a group of conditions known as ANCAassociated vasculitis (AAV). The cause of AAV is unknown. AAV has an annual incidence of 20 per million and an approximate prevalence of 200/million. It is a multi-system autoimmune disease that causes tissue damage especially to the respiratory tract and kidneys and causes early mortality, organ failure including end-stage renal disease, and chronic morbidity. Prior to the availability of effective treatment, AAV was almost universally fatal, with a 93% mortality within 2 years due to pulmonary and renal failure. Administration of cytotoxic immunosuppression (cyclophosphamide, rituximab, methotrexate) and glucocorticoids (GC) for at least one year induces remission in approximately 80% of patients. GC are a standard of care in the treatment of AAV. High doses of GC early in disease although undeniably reduce disease activity due to their anti-inflammatory and immunosuppressive properties also increase the risk of infection particularly in the elderly and in the presence of uremia. There is a major unmet need for safer therapy that leads to sustained treatment free remission in patients with relapsing disease, which will reduce drug toxicity that results from cumulative exposure to immunosuppression and glucocorticoids.
This randomized controlled trial aims to evaluate the effects of using low-dose glucocorticoids as compared to stopping glucocorticoid treatment entirely.
View more about this trial in ClinicalTrials.gov
Hand Osteoarthritis
A Pilot Randomized Controlled Trial of Hand Traction for Nodal Osteoarthritis
Hand osteoarthritis (OA) is a common problem and is associated with substantial functional limitations. To date, few therapies are effective in reducing pain in hand OA; and most are only based on expert opinion. Although nodal hand OA has traditionally not been viewed as a biomechanically driven disease, there is growing evidence that indeed it is. OA in the knee, a disease long known to be biomechanically driven, can be treated with distraction, a therapy where external hardware is surgically placed preventing joint motion, providing intra-articular negative pressure, and increasing the joint space. People awaiting knee total knee arthroplasty receiving distraction have reduced pain, growth of new articular cartilage, and delay and sometimes complete avoidance of arthroplasty. Unfortunately, distraction is associated with serious attendant adverse events including a 10% rate of pulmonary emboli despite anticoagulation and an 85% rate of pin site infection, limiting the widespread use of this treatment. Nevertheless, it is an important proof of concept that unloading an OA joint may allow structure and symptom improvement. Since distraction has both symptom and structure benefits in knee OA, then traction therapy, using non-invasive finger traps, may have similar benefits for hand OA without attendant complications. Thus, this study proposes a pilot randomized controlled trial of traction on 100 participants recruited from the Michael E. DeBakey VA Medical Center with at least 3 joints affected by distal interphalangeal (DIP) nodal hand OA, with at least one symptomatic joint.
View more about this trial in ClinicalTrials.gov
Knee Osteoarthritis
The Use of Senolytic and Anti-Fibrotic Agents to Improve the Beneficial Effect of Bone Marrow Stem Cells for Osteoarthritis
Osteoarthritis (OA) is a progressive joint disease leading to cartilage damage, pain, and loss of function. While many stem cell therapies for OA are under investigation, none are currently FDA-approved for modifying the course of the disease. Of the many adult stem cell types potentially applicable to OA, bone marrow stem cells (BMSCs) from bone marrow aspirate concentrate (BMC) are the most clinically translatable (and are already in clinical use) since they can be harvested using minimally invasive technology and do not require in vitro expansion. There is, however, significant potential for improving efficacy of BMSC treatment for OA. The number of senescent cells in BMC increases with age and OA, and these cells release pro-inflammatory cytokines/chemokines, proteases, and other senescence-associated secretory phenotypes (SASP) that can impair stem cell function and likely contribute to OA development/progression. Based on the previous findings, the senolytic agents can delay OA in a preclinical model, and also blocking fibrosis with Losartan (a TGF-β1blocker) can improve cartilage repair by promoting regeneration of hyaline cartilage while reducing the amount of fibrocartilage. Thus, this study hypothesizes that the administration of senolytic and/or anti-fibrotic agents will enhance the beneficial effect of BMSCs for treating OA.
View more about this trial in ClinicalTrials.gov
Knee Replacement
Reducing Sedentary Time Using an Innovative mHealth Intervention Among Total Knee Replacement Patients
The number of individuals undergoing total knee replacement (TKR) each year continues to rise. While TKR is effective for improving pain and function, subsequent improvements in physical activity are not common. As a result, patients spend most of their day engaged in sedentary behavior, which may put them at higher risk of experiencing poor function and disability, as well as lower the overall success of the surgical treatment. Intervening on sedentary time, rather than physical activity, may be a more feasible first-step approach for modifying activity-related behaviors in this population. Therefore, the purpose of this innovative clinical trial is to use TKR as a teachable moment for implementing a sedentary reduction intervention. This study proposes to use a just-in-time mobile health (mHealth) intervention to reduce sedentary time among TKR patients.
View more about this trial at ClinicalTrials.gov
Meniscal tear and Osteoarthritis (OA)
Treatment of Meniscal Problems in Osteoarthritis
Knee osteoarthritis is a disabling problem affecting over 15 million adults in the United States. Many people who have knee arthritis also experience painful meniscal tears. There are a number of different treatments that can be used to manage meniscal tears in the presence of knee arthritis. Treatments include surgically removing the damaged part of the meniscus; strengthening exercises to improve pain and function; manual therapy including massage and mobilization; acupuncture; and others. The combination of surgery and exercise therapy was long thought to be the best treatment. However, recent studies have shown that surgery followed by physical therapy is no more effective than physical therapy by itself.
While physical therapy alone has been shown to result in similar pain relief as arthroscopic surgery, researchers have not yet done studies to determine what type of physical therapy is best for people with knee arthritis and meniscal tears. This study proposes the TeMPO (Treatment of Meniscal Problems in Osteoarthritis) Trial to compare different non-operative physical therapy regimens to gain a better understanding of how physical therapy works and what regimen will best reduce pain and improve function in persons with meniscal tear and osteoarthritis.
View more about this trial in ClinicalTrials.gov
Pompe Disease
A Phase 1 Study of the Safety of AAV2/8-LSPhGAA in Late-onset Pompe Disease
The development of gene therapy has advanced to a point where a cure for Pompe disease can be foreseen. Pompe disease (glycogen storage disease type II; acid maltase deficiency) is a devastating muscle disease resulting from acid alpha-glucosidase (GAA) deficiency in striated and smooth muscle. Despite the availability of enzyme replacement therapy (ERT) with recombinant human (rh) GAA, many patients have poor outcomes including death due to clinically significant anti-GAA antibody response. The limitations of ERT have prompted the preclinical development of gene therapy for Pompe disease. Clinical translation of efficacious gene therapy will greatly advance treatment for Pompe disease by correcting GAA deficiency and suppressing immune responses against rhGAA.
The long-term goal of the study is to develop curative therapy for Pompe disease. Toward this end we have developed gene therapy with an adeno-associated virus (AAV) vector that expresses GAA specifically in the liver accompanied by GAA secretion and receptor-mediated uptake of GAA in the heart and skeletal muscle. It is the central hypothesis that continuous GAA production from a liver depot will surpass the benefits achieved with ERT in Pompe disease.
View more about this trial in ClinicalTrials.gov
Systemic Lupus Erythematosus (SLE)
Study of Anti-Malarials in Incomplete Lupus Erythematosus
Systemic lupus erythematosus (SLE) causes major organ damage and shortens lifespan in relatively young persons. Early diagnosis and treatment are essential to improving outcomes for SLE patients. However, evidence-based approaches to early treatment interventions and the appropriate target population for these interventions are not available. We propose that individuals who have positivity for antinuclear antibodies (ANAs) and who also exhibit some of the other features that are used to classify SLE, are at high risk of progressing to the full systemic form of this disease. These individuals, who have significant levels of ANA with 1 or 2 additional items from the lupus classification criteria, are considered to have incomplete lupus erythematosus (ILE).
The primary objective is to determine whether HCQ treatment can prevent acquisition of additional clinical and immunologic features that define SLE. The secondary objectives are to determine whether HCQ treatment 1) lessens lupus disease activity as measured by standard scoring indices, 2) improves patient-reported outcomes, 3) prevents accumulation of immunologic abnormalities including autoantibodies and cytokines, and 4) has an acceptable toxicity profile.