Rheumatoid Arthritis (RA)Phase 1/2NCT03160001
Niclosamide With Etanercept in Rheumatoid Arthritis
A Phase 1/2 study testing Niclosamide and Etanercept in people with Rheumatoid Arthritis (RA), run by Faiq Gorial at 1 site in Iraq.
Trial summary
Assessment of the adjuvant use Niclosamide With Etanercept in Rheumatoid Arthritis Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- Niclosamide and Etanercept
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteIraq
- Study dates
- 15 Aug 2017to 10 Dec 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with RA, as defined by the American College of Rheumatology (ACR) 1987 revised criteria or ACR/EULAR 2010,
- Severly Active RA by calculating either DAS28 or SDAI or CDAI.
- Patient selected are those who started etanercept for less than 3months and still active.
Who cannot join
- Patients on nonsteroidal anti-inflammatory drugs (NSAID) 2 days before entry into this study. or methotrexate (MTX)..
- Patients with hypersensitivity or severe adverse effects to niclosamide .
- Renal impairment.
- Hepatic impairment.
- Pregnancy or a desire to become pregnant.
- Breast feeding.
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- Patients with Juvenile RA [16 years old or younger].
- Patients using other conventional disease modifying antirheumatic drugs (DMARDs).
- Patients on steroid.
- Patients with coexistence other connective tissue diseases or hypothyroid disease.
- Patient with mild or inactive RA.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjuvant Use of Niclosamide With Etanercept in Rheumatoid Arthritis: Experimental and Clinical Study
Assessment of the adjuvant use Niclosamide With Etanercept in Rheumatoid Arthritis
Read the detailed description
In this randomized double blind placebo-controlled pilot study (Phase I study) we will assess the efficacy and safety of adjuvant use Niclosamide With Etanercept in Rheumatoid Arthritis.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- Placebo, Niclosamide, Etanercept
- Keywords
- Niclosamide, Rheumatoid arthritis, diseases activity, Efficacy, Safety
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Lactose
Patients with active RA and receive Etanercept for 8 weeks.: Placebo lactose 500mg cap twice daily
NiclosamideDrug
Patients with active RA and receive etanercept with niclosamide cap 500mg twice daily orally as adjuvant therapy for 8 weeks
EtanerceptDrug
Also called Enbrel
Etanercept 50mg weekly
| Study group | Role | What they receive |
|---|---|---|
| Placebo and etanercept | Placebo comparator | Placebo lactose 500mg cap twice daily with etanercept 50mg weekly for 8 weeks Receives: Drug: Placebo; Drug: Etanercept |
| Niclosamide and etanercept | Experimental | Niclosamide cap 500 mg twice daily with Etanercept 50mg weekly for 8 weeks Receives: Drug: Niclosamide; Drug: Etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in disease activity scale
Mean change of disease activity index from baseline using clinical disease activity index (CDAI).
Measured: Day 1
Secondary outcomes (4)
Change in disease activity score
Mean change of disease activity index from baseline using simplified disease activity index (SDAI).
Measured: Day 2
disease activity change scale
Mean change of disease activity index from baseline using disease activity score 28 joints-erythrocyte sedimentation rate (DAS28-ESR).
Measured: Day 3
The Change in disease activity scale
Mean change of disease activity index from baseline using health assessment quality of life (HAQDI).
Measured: 24 hours to 48 hours day
safety of niclosamide
Number of participants with treatment-related adverse events
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start15 Aug 2017
- Primary completion15 Aug 2018
- Study completion10 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1 patient group and 1 placebo group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faiq Gorial
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Faiq Gorial, University of Baghdad
- Investigators
- Ahmed S Mahmood, MSc, Principal investigator, Baghdad Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160001
- Sponsor's protocol ID
- PRO17050001
- Status last verified
- Dec 2018
- First submitted
- 11 May 2017
- Last updated
- 12 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Use of Niclosamide With Etanercept in Rheumatoid Arthritis: Experimental and Clinical Study
- ClinicalTrials.gov ID
- NCT03160001
- Acronym / sponsor ID
- PRO17050001
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- Niclosamide, Rheumatoid arthritis, diseases activity, Efficacy, Safety
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Faiq GorialUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 15 Aug 2018 (actual)
- Study completion
- 10 Dec 2018 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of the adjuvant use Niclosamide With Etanercept in Rheumatoid Arthritis
Detailed description
In this randomized double blind placebo-controlled pilot study (Phase I study) we will assess the efficacy and safety of adjuvant use Niclosamide With Etanercept in Rheumatoid Arthritis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 1 patient group and 1 placebo group
| Arm | Type | Receives |
|---|---|---|
| Placebo and etanercept | Placebo comparator | Drug: Placebo, Drug: EtanerceptPlacebo lactose 500mg cap twice daily with etanercept 50mg weekly for 8 weeks |
| Niclosamide and etanercept | Experimental | Drug: Niclosamide, Drug: EtanerceptNiclosamide cap 500 mg twice daily with Etanercept 50mg weekly for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with RA, as defined by the American College of Rheumatology (ACR) 1987 revised criteria or ACR/EULAR 2010,
- Severly Active RA by calculating either DAS28 or SDAI or CDAI.
- Patient selected are those who started etanercept for less than 3months and still active.
Key exclusion criteria (11 listed)
- Patients on nonsteroidal anti-inflammatory drugs (NSAID) 2 days before entry into this study. or methotrexate (MTX)..
- Patients with hypersensitivity or severe adverse effects to niclosamide .
- Renal impairment.
- Hepatic impairment.
- Pregnancy or a desire to become pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: LactosePatients with active RA and receive Etanercept for 8 weeks.: Placebo lactose 500mg cap twice daily | Drug | Placebo and etanercept |
| NiclosamidePatients with active RA and receive etanercept with niclosamide cap 500mg twice daily orally as adjuvant therapy for 8 weeks | Drug | Niclosamide and etanercept |
| EtanerceptAlso: EnbrelEtanercept 50mg weekly | Drug | Niclosamide and etanercept, Placebo and etanercept |
Primary outcome
Change in disease activity scale
Time frame: Day 1
Mean change of disease activity index from baseline using clinical disease activity index (CDAI).
4 secondary outcomes
Change in disease activity score
Time frame: Day 2
disease activity change scale
Time frame: Day 3
The Change in disease activity scale
Time frame: 24 hours to 48 hours day
safety of niclosamide
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed S Mahmood, MSc principal investigator
Baghdad Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Niclosamide and Etanercept in people with Rheumatoid Arthritis (RA), run by Faiq Gorial at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in disease activity scale (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2018.