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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
Must not have
Prolonged corrected QT interval or concurrent medications that prolong QT interval
Diagnosis of immunodeficiency
Timeline
Screening 3 weeks
Treatment Varies
Follow Up upon completion of follow-up period, an average of 3 years after intervention
Awards & highlights
All Individual Drugs Already Approved
Approved for 30 Other Conditions

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My heart's electrical cycle is longer than normal or I take medication that can extend this cycle.
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I have been diagnosed with an immune system disorder.
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I have an active heart condition.
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I weigh less than 40 kg.
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I have a history of inflammatory arthritis such as rheumatoid arthritis or lupus.
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I need medication to suppress my immune system.
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I have G6PD deficiency, porphyria, or psoriasis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~upon completion of follow-up period, an average of 3 years after intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and upon completion of follow-up period, an average of 3 years after intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Recurrence of grade ≥2 Immune-Related Arthritis or Arthralgia
Secondary study objectives
Adverse Event
Development of immune related adverse events (irAE's) other than irAA
Progression free survival
+3 more

Side effects data

From 2016 Phase 3 trial • 217 Patients • NCT02057250
13%
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%
Wolff-Parkinson-White syndrome
1%
Coronary artery occlusion
1%
Anaemia
1%
Leukopenia
1%
Lumbar spinal stenosis
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)

Awards & Highlights

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.

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
26,785 Total Patients Enrolled
Michael KolinskyPrincipal InvestigatorAHS-CCI
3 Previous Clinical Trials
463 Total Patients Enrolled

Media Library

Hydroxychloroquine (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04354649 — Phase 2
Back Pain Research Study Groups: Hydroxychloroquine, plus prednisone, Hydroxychloroquine-matching placebo, plus prednisone
Back Pain Clinical Trial 2023: Hydroxychloroquine Highlights & Side Effects. Trial Name: NCT04354649 — Phase 2
Hydroxychloroquine (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04354649 — Phase 2
~7 spots leftby Jul 2025
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