Table of Contents
- Trial overview
- Conditions studied
- Study designs and phases
- What the trials measure
- Who is being studied
- Trial status and size
Trial overview
The trial data show that Hydroxychloroquine Sulfate is being studied in many different clinical settings, including autoimmune disease, pregnancy-related conditions, kidney disease, mastocytosis, multiple sclerosis, and cancer.[1]
Some studies test it alone versus placebo, while others study it as part of a combination treatment or compare it with standard care.[2]
Conditions studied
The largest group of studies focus on rheumatoid arthritis, including trials in early disease, active disease, and disease that has not improved enough with earlier treatment.[3]
Other autoimmune and inflammatory conditions include primary Sjögren’s syndrome, extra pulmonary sarcoidosis, systemic sclerosis, idiopathic inflammatory myopathy, calcium pyrophosphate deposition disease, mastocytosis, and IgA nephropathy.[4]
The trial set also includes studies in multiple sclerosis, antiphospholipid antibodies, recurrent pregnancy loss, metastatic refractory pancreatic cancer, and resectable head and neck or non-small cell lung cancer.[5]
Study designs and phases
The studies include Phase 2, Phase 3, Phase 4, and Low Intervention designs.[6]
Phase 2 trials in this set are used to explore early benefit and biological effects, such as changes in brain imaging, inflammation, or pregnancy outcomes.[5]
Phase 3 trials are larger and often compare Hydroxychloroquine Sulfate with placebo or with other treatment strategies, such as steroid-sparing treatment in sarcoidosis or add-on treatment in systemic sclerosis.[7]
The Low Intervention study in rheumatoid arthritis compares treatment strategies and looks at disease activity and use of advanced medicines over time.[8]
What the trials measure
The main primary outcomes include symptom improvement, remission, and changes in disease activity scores.[3]
Some trials measure lung function using forced vital capacity, which is a test of how much air a person can breathe out after a deep breath.[9]
Other trials measure kidney function with GFR slope, which means the change in glomerular filtration rate over time and shows how well the kidneys are working.[10]
Several studies use imaging or tissue tests, such as TSPO-PET in multiple sclerosis, immunohistochemical markers in cancer, and CD68 scoring in calcium pyrophosphate deposition disease.[5]
Pregnancy studies measure outcomes such as pregnancy loss, preterm birth, and live birth rate.[11]
Safety is also a major focus in some trials, including monitoring adverse events, vital signs, ECG results, and laboratory tests.[12]
Who is being studied
Most trials enroll adults, and several focus on people with active disease, meaning the condition is currently causing symptoms or test changes.[1]
Some studies are limited to people with biopsy-proven disease, such as IgA nephropathy, or to people with specific pregnancy-related antibody findings, such as antiphospholipid antibodies.[10]
Other trials focus on patients who have not responded well to previous therapy, such as rheumatoid arthritis after methotrexate or leflunomide, or metastatic refractory pancreatic cancer.[6]
Trial status and size
In the provided data, most studies are listed as Authorised, and a smaller number are marked Completed.[7]
Enrollment ranges from small proof-of-concept studies with 20 to 34 participants to larger trials with more than 700 participants.[3]
This wide range shows that Hydroxychloroquine Sulfate is being tested both in small early studies and in larger studies meant to compare treatment choices more fully.[6]
