Hydroxychloroquine for Joint Pain
(IMPACT 2 Trial)
Recruiting in Palo Alto (17 mi)
Overseen byMichael Kolinsky
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: AHS Cancer Control Alberta
Must not be taking: Immunosuppressants, Corticosteroids
Disqualifiers: Inflammatory arthritis, Cardiovascular disease, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?Many people develop joint pain, stiffness and swelling due to their cancer treatment that targets the immune system. The severity of symptoms ranges from mild to debilitating and sometimes requires delaying or stopping cancer treatment.
The usual plan is to discontinue cancer treatment and give relatively high doses of a medication called prednisone (a steroid, which is an anti-inflammatory medication which may suppress the immune system) with a gradual lowering of the dose over several weeks. While this can be effective, prednisone can cause a number of side effects, and it is not known if this is the best or safest treatment.
Hydroxychloroquine is a medication that is often used to treat inflammatory joint pain, such as rheumatoid arthritis, has relatively few side effects when compared to prednisone, and may be effective at treating this condition.
The purpose of this study is to find out whether it is better to receive hydroxychloroquine and prednisone, or prednisone alone for joint pain. To do this, some participants will get hydroxychloroquine and some will receive a placebo (a substance that looks like the study drug but does not have any active or medicinal ingredients). A placebo is used to make the results of the study more reliable.
This is a double-blinded study, which means that neither participants nor the study doctor or study staff will know which group participants are allocated. After 12 weeks of study treatment, the blind will be opened and participants will be informed which treatment was given.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop your current medications. However, it mentions that current use of certain immunosuppressive medications is not allowed, except for specific types like inhaled or topical steroids. It's best to discuss your specific medications with the study team.
What evidence supports the effectiveness of the drug hydroxychloroquine for joint pain?
Research shows that hydroxychloroquine is effective in reducing symptoms in conditions like rheumatoid arthritis and systemic lupus erythematosus, which often involve joint pain. It is well-tolerated and can help decrease disease activity and inflammation.
12345Is hydroxychloroquine safe for humans?
Hydroxychloroquine is generally considered safe, but it can cause side effects like skin rashes, eye problems, and stomach issues. Rarely, it can lead to severe skin reactions or heart and eye problems, so it's important to monitor for these effects.
26789How is the drug hydroxychloroquine unique in treating joint pain?
Hydroxychloroquine is unique because it is traditionally used to treat inflammation in conditions like rheumatoid arthritis and lupus, and it may help reduce joint pain by targeting synovitis (inflammation of the joint lining) in osteoarthritis, which is not commonly addressed by other treatments.
110111213Eligibility Criteria
This trial is for adults over 18 with cancer-related joint pain from immune therapy, who can consent to treatment and have a decent performance status. They must not have inflammatory arthritis or other conditions needing immunosuppressants, no severe allergies to the study drug, and should follow birth control guidelines.Inclusion Criteria
I agree not to donate sperm during and for 3 months after the study.
I am able to understand and agree to the study's requirements.
I am 18 years old or older.
+7 more
Exclusion Criteria
My heart's electrical cycle is longer than normal or I take medication that can extend this cycle.
I have been diagnosed with an immune system disorder.
I have experienced side effects from immunotherapy that are moderate or worse, excluding insulin-dependent diabetes.
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either hydroxychloroquine and prednisone or a placebo and prednisone for joint pain
12 weeks
Regular visits for monitoring and assessment
Follow-up
Participants are monitored for safety and effectiveness after treatment
1 year
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
Up to 3 years
Participant Groups
The trial tests if Hydroxychloroquine combined with prednisone is better than prednisone alone for treating joint pain caused by cancer immune treatments. Participants are randomly given either Hydroxychloroquine or a placebo without knowing which one they receive.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Hydroxychloroquine, plus prednisoneExperimental Treatment1 Intervention
Hydroxychloroquine 5mg/kg PO daily, plus prednisone starting at 20 mg PO daily for 8 weeks tapering dose.
Group II: Hydroxychloroquine-matching placebo, plus prednisonePlacebo Group1 Intervention
Matching placebo daily, plus prednisone starting at 20 mg PO daily for 8 weeks tapering dose.
Hydroxychloroquine is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Plaquenil for:
- Malaria
- Rheumatoid Arthritis
- Systemic Lupus Erythematosus
🇪🇺 Approved in European Union as Plaquenil for:
- Malaria
- Rheumatoid Arthritis
- Systemic Lupus Erythematosus
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cross Cancer InstituteEdmonton, Canada
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Who Is Running the Clinical Trial?
AHS Cancer Control AlbertaLead Sponsor
References
Comparison of hydroxychloroquine and placebo in the treatment of the arthropathy of mild systemic lupus erythematosus. [2013]To compare the relative safety and efficacy of hydroxychloroquine (HCQ) and placebo (Pl) in the treatment of the articular complaints of systemic lupus erythematosus (SLE).
Rheumatoid arthritis. New developments in treatment. [2019]If a patient with active rheumatoid arthritis does not obtain significant relief from nonsteroidal anti-inflammatory drugs, prompt institution of disease-modifying antirheumatic drugs (DMARDs) is recommended. If one agent fails, another may be tried. At present, hydroxychloroquine (Plaquenil) sulfate is one of the most widely used and best tolerated. Careful follow-up is essential with all DMARDs, however, because toxic effects may be severe and sometimes unpredictable.
Relationship of cytochrome P450 gene polymorphisms with blood concentrations of hydroxychloroquine and its metabolites and adverse drug reactions. [2022]Hydroxychloroquine (HCQ) is a cornerstone therapy for systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA). This study aimed to investigate the relationship of cytochrome P450 (CYP450) gene polymorphisms with blood concentrations of HCQ and its metabolites and adverse drug reactions (ADRs) in patients with SLE and RA.
Combination therapy with gold and hydroxychloroquine in rheumatoid arthritis: a prospective, randomized, placebo-controlled study. [2019]We studied combination therapy with two slow-acting antirheumatic drugs given concurrently in active rheumatoid arthritis (RA). A 12-month prospective randomized controlled trial compared gold and hydroxychloroquine in 52 patients to gold and placebo in 49. The patients continued to receive non-steroidal anti-inflammatory drugs and analgesics. They were selected from three rheumatology centres in the West Midlands. Combination therapy led to a greater number of withdrawals due to adverse reactions (18 cases compared to 10 receiving gold/placebo). Patients completing 12 months' therapy (27 taking gold/hydroxychloroquine and 32 on gold/placebo) were compared using five clinical, seven laboratory, and one radiological measure. All 13 variables favoured gold/hydroxychloroquine with an overall advantage of 20-25% for the combination. This only reached statistical significance (at the 1% level) for C-reactive protein. An overall disease activity index was better at 12 months (at the 5% level) and showed a more rapid response with gold/hydroxychloroquine. This is the first randomized prospective placebo-controlled trial to show a significant advantage from a combination of two slow-acting drugs. There are many different ways of giving such combinations and we consider these should be explored to maximize the effectiveness of treatment for RA.
The biological and clinical activity of anti-malarial drugs in autoimmune disorders. [2019]Chloroquine and hydroxychloroquine are 4-aminoquinoline compounds commonly employed as anti-malarial drugs. Chloroquine and its synthetic analogue, hydroxychloroquine also belong to the disease-modifying anti-rheumatic drug class because these drugs are immunosuppressive. The immunosuppressive activity of chloroquine and hydroxychloroquine is likely to account for their capacity to reduce T-cell and B-cell hyperactivity as well as pro-inflammatory cytokine gene expression. This review evaluated experimental and clinical trials results as well as clinical response data relative to the use of chloroquine and/or hydroxychloroquine as first-line medical therapies in systemic lupus erythematosus, rheumatoid arthritis, primary Sjogren's syndrome, the anti-phospholipid syndrome and in the treatment of sarcoidosis. A primary outcomes measure in these clinical trials was the extent to which chloroquine and/or hydroxychloroquine reduced disease progression or exacerbations and/or the use and dosage of corticosteroids. The relative efficacy of chloroquine and hydroxychloroquine in modifying the clinical course of these autoimmune disorders is balanced against evidence that these drugs induce adverse effects which may reduce their use and effectiveness in the therapy of autoimmune disorders.
Retinal toxicity secondary to Plaquenil therapy. [2016]Hydroxychloroquine sulfate (Plaquenil; Sanofi-Aventis, Bridgewater, New Jersey) is an antimalarial agent, which is sometimes used for the treatment of certain autoimmune disorders. Its use has been associated with ocular side effects; the most concerning is toxic maculopathy.
A case of an acute cutaneous drug reaction with hydroxychloroquine. [2018]Hydroxychloroquine is considered a relatively benign drug and is regularly used by rheumatologists and dermatologists. We highlight the severe adverse drug reaction potential of this commonly prescribed medication. We report the case of a 63-year-old male, who presented with widespread skin eruption following initiation of hydroxychloroquine two weeks earlier for an inflammatory arthritis. He had typical clinical, biochemical and histological features of the now recognised formal 'diagnosis' of severe cutaneous adverse drug reaction. The culprit drug was stopped and he responded to oral and topical steroids as well as supportive measures. Severe reactions to hydroxychloroquine are uncommon; however, as in this case, drug hypersensitivity reactions often manifest in skin. In a drug normally considered to be safe, these potential cutaneous side effects should be highlighted in information given to patients prior to commencement.
[Hallucinations during treatment with hydrochloroquine]. [2019]We report an unexpected cenesthetic hallucination-type neuropsychiatric side effect with hydrochloroquine (Plaquenil) in a patient treated for an erosive plantar lichen planus.
The safety profile of hydroxychloroquine: major cutaneous and extracutaneous adverse events. [2022]Hydroxychloroquine is an established therapy for several rheumatological disorders, and very recently it has been proposed as a possible treatment for the new coronavirus disease 2019 even if recent randomised trials did not prove any benefit. Notably, hydroxychloroquine has been associated with a heterogeneous range of cutaneous and extra-cutaneous adverse events. We carried out a narrative review of the literature up to November 1st, 2020, related to the safety of hydroxychloroquine. In particular, cutaneous and extra-cutaneous adverse events associated with hydroxychloroquine were reviewed. The following databases were consulted: PubMed, Embase, Google Scholar and ResearchGate. The research of articles was conducted by using the following search terms: ''hydroxychloroquine," ''adverse event/effect,'' "cutaneous", "skin", "cardiotoxicity", "retinopathy", gastrointestinal and neurological toxicity". The main indication for which hydroxychloroquine was used in the reports was an immune mediated disorder. Adverse events were described mostly in females over 50 years of age. The most common cutaneous adverse effect was maculopapular and erythematous rash occurring within 4 weeks of initiating hydroxychloroquine and disappearing within few weeks of discontinuation. Gastrointestinal symptoms and headache were the most frequent extracutaneous manifestations. Rarer cutaneous manifestations include hyperpigmentation, psoriasiform dermatitis, photodermatitis, stomatitis, melanonychia and hair loss. More severe conditions were acute generalised exanthematous pustulosis, drug rash with eosinophilia and systemic symptoms, Stevens-Johnson syndrome/toxic epidermal necrolysis, and among extra-cutaneous adverse events cardiotoxicity and retinopathy. Since hydroxychloroquine is widely prescribed in rheumatology, it is important for rheumatologists to be familiar with its safety profile.
Hydroxychloroquine effectiveness in reducing symptoms of hand osteoarthritis (HERO): study protocol for a randomized controlled trial. [2021]Osteoarthritis (OA) is the most common type of arthritis, causing significant joint pain and disability. It is already a major cause of healthcare expenditure and its incidence will further increase with the ageing population. Current treatments for OA have major limitations and new analgesic treatments are needed. Synovitis is prevalent in OA and is associated with pain. Hydroxychloroquine is used in routine practice for treating synovitis in inflammatory arthritides, such as rheumatoid arthritis. We propose that treating patients with symptomatic hand OA with hydroxychloroquine will be a practical and safe treatment to reduce synovitis and pain.
Association Between Autoantibody Phenotype and Cutaneous Adverse Reactions to Hydroxychloroquine in Dermatomyositis. [2019]Hydroxychloroquine sulfate is a commonly used medication for patients with dermatomyositis and has been associated with a uniquely elevated risk of adverse cutaneous reactions in this population. No studies to date have examined whether certain subsets of patients with dermatomyositis are at increased risk of experiencing a hydroxychloroquine-associated skin eruption.
Therapy and pharmacological properties of hydroxychloroquine and chloroquine in treatment of systemic lupus erythematosus, rheumatoid arthritis and related diseases. [2022]This review examines the pharmacokinetics, modes of action and therapeutic properties of the anti-malarial drugs, hydroxychloroquine (HCQ) and chloroquine (CQ), in the treatment of systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) and related conditions, as well as osteoarthritis (OA).
Hydroxychloroquine decreases Th17-related cytokines in systemic lupus erythematosus and rheumatoid arthritis patients. [2023]Hydroxychloroquine is an antimalarial agent that has been used in systemic lupus erythematosus and rheumatoid arthritis treatment for many years. Recently, novel mechanisms of action have been proposed, thereby broadening the therapeutic perspective of this medication. The purpose of this study was to evaluate the immunomodulatory activity of hydroxychloroquine in T helper 17 (Th17) cytokines in healthy individuals and patients.