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Hydroxychloroquine for Joint Pain (IMPACT 2 Trial)
Phase 2
Recruiting
Led By Michael Kolinsky
Research Sponsored by AHS Cancer Control Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male patients should agree to not donate sperm during the study and for a period of at least 3 months after last dose of study drug
Patients must be 18 years of age, or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up upon completion of follow-up period, an average of 3 years after intervention
Awards & highlights
IMPACT 2 Trial Summary
This trial is testing whether hydroxychloroquine is better than prednisone for joint pain caused by cancer treatment.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Hydroxychloroquine may cause mild side effects like stomach upset, headache, dizziness, or skin rash. In contrast to prednisone's more extensive side effects such as increased appetite, mood changes, trouble sleeping and potential risk of infection.
IMPACT 2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree not to donate sperm during and for 3 months after the study.
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I am 18 years old or older.
Select...
My liver and kidney tests are within normal ranges.
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I am able to get out of my bed or chair and move around.
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I developed arthritis or joint pain from cancer immunotherapy.
IMPACT 2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ upon completion of follow-up period, an average of 3 years after intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~upon completion of follow-up period, an average of 3 years after intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recurrence of grade ≥2 Immune-Related Arthritis or Arthralgia
Secondary outcome measures
Adverse Event
Development of immune related adverse events (irAE's) other than irAA
Progression free survival
+3 moreSide effects data
From 2016 Phase 3 trial • 217 Patients • NCT0205725013%
Upper respiratory tract infection
6%
Neutropenia
6%
Sinusitis
5%
Alanine aminotransferase increased
5%
Urinary tract infection
4%
Injection site erythema
4%
Accidental overdose
4%
Bronchitis
3%
Injection site pruritus
2%
Thrombocytopenia
2%
Nasopharyngitis
2%
Contusion
1%
Arthralgia
1%
Anaemia
1%
Lumbar spinal stenosis
1%
Leukopenia
1%
Coronary artery occlusion
1%
Wolff-Parkinson-White syndrome
1%
Transient ischaemic attack
1%
Vertebrobasilar insufficiency
1%
Chronic obstructive pulmonary disease
1%
Small intestinal obstruction
1%
Nephrolithiasis
1%
Cataract
1%
Thrombophlebitis superficial
1%
Vomiting
1%
Endometrial hyperplasia
1%
Traumatic arthritis
1%
Hypertension
1%
Pneumonia
1%
Pancreatic carcinoma metastatic
1%
Osteoarthritis
1%
Rheumatoid lung
1%
Pharyngitis
1%
Femoral neck fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sarilumab 150 mg by PFS (Extension Phase)
Sarilumab 150 mg by AID (AID Assessment Phase)
Sarilumab 150 mg by PFS (AID Assessment Phase)
Sarilumab 200 mg by PFS (AID Assessment Phase)
Sarilumab 200 mg by AID (AID Assessment Phase)
IMPACT 2 Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydroxychloroquine
FDA approved
Find a Location
Who is running the clinical trial?
AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
36,166 Total Patients Enrolled
1 Trials studying Arthritis
27 Patients Enrolled for Arthritis
Michael KolinskyPrincipal InvestigatorAHS-CCI
2 Previous Clinical Trials
227 Total Patients Enrolled
1 Trials studying Arthritis
27 Patients Enrolled for Arthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 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 have experienced side effects from immunotherapy that are moderate or worse, excluding insulin-dependent diabetes.I have an active heart condition.I am 18 years old or older.I am a woman who can have children and have a negative pregnancy test.I weigh less than 40 kg.My liver and kidney tests are within normal ranges.You have other serious medical conditions or mental health issues that might make it unsafe for you to take part in the study.I have a history of inflammatory arthritis such as rheumatoid arthritis or lupus.I am able to get out of my bed or chair and move around.I need medication to suppress my immune system.You have had a strong allergic reaction to the study drug or any of its ingredients in the past.I am not breastfeeding or will stop before starting the treatment and won't breastfeed for 3 months after.I have G6PD deficiency, porphyria, or psoriasis.I developed arthritis or joint pain from cancer immunotherapy.I am not on immunosuppressive medication, except for allowed cases.
Research Study Groups:
This trial has the following groups:- Group 1: Hydroxychloroquine, plus prednisone
- Group 2: Hydroxychloroquine-matching placebo, plus prednisone
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 30 Other Conditions - This treatment demonstrated efficacy for 30 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent has Hydroxychloroquine been explored in prior scientific research?
"Presently, the research surrounding Hydroxychloroquine is extensive with 394 ongoing trials and 99 Phase 3 clinical studies. Duarte, California hosts multiple of these investigations; however, there are an astonishing 17185 sites conducting experiments involving this medication."
Answered by AI
What medical applications does Hydroxychloroquine typically have?
"Hydroxychloroquine is widely utilized to manage lupus erythematosus, as well as q fever, thyroiditis, and ulcerative colitis."
Answered by AI
What is the current cohort size for this clinical research?
"Affirmative, according to the information hosted on clinicaltrials.gov this medical research is open for recruitment. Starting from July 29th 2021 and most recently updated on October 20th 2021, 46 participants are in need of being enrolled at one site."
Answered by AI
Is this experiment in progress with new participants?
"Clinicaltrials.gov affirms that this medical trial, originally posted on July 29th 2021, is presently recruiting patients for participation. The last update to the protocol was made on October 20th 2021."
Answered by AI
Does the FDA recognize Hydroxychloroquine as a legitimate treatment?
"Hydroxychloroquine safety was rated a 2 due to the presence of some evidence indicating its safety, yet no studies validating its efficacy."
Answered by AI
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