Active Rheumatoid ArthritisPhase 3NCT02534896
To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis
A Phase 3 study testing Treatment I, Treatment II and Treatment III in people with Active Rheumatoid Arthritis, run by Sun Pharmaceutical Industries Limited at 20 sites in 2 countries.
Trial summary
This study is designated to evaluate the safety and efficacy of Sunpharma1505 in subjects with active rheumatoid arthritis who are experiencing a flare/exacerbation. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Active Rheumatoid Arthritis
- What is being tested?
- Treatment I, Treatment II and Treatment III
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 20 sitesin 2 countries
- Study dates
- Nov 2015to Jun 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects able and willing to give written informed consent and is available for entire study.
- Male or female ≥ 18 years old
- Willing and able to comply with the study protocol visits, assessments and accessible for follow up
- Known Diagnosed Rheumatoid arthritis
- Subjects of child bearing potential should be non-lactating and must be practicing an acceptable method of birth control as judged by the Investigator
Who cannot join
- Subjects who are pregnant or intend to become pregnant during the study
- Subject with positive hepatitis panel and / or anti-hepatitis B core antibodies, and / or hepatitis C virus antibody [anti-HCV]), and / or a positive Human immunodeficiency virus (HIV) antibody.
- Known sensitivity to any component of the study drug or previous hypersensitivity reaction or other clinically significant reaction to IV medications, biologic therapy or IV radiocontrast agents.
- Active infection requiring systemic treatment
- Planned surgery during the study period or had undergone major surgery within the 60 Days prior to the Screening visit.
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
Netherlands12 sites
Sun Pharma Site 11
Amsterdam
Sun Pharma Site 9
Amsterdam
Sun Pharma Site 6
Enschede
Sun Pharma Site 4
Heerlen
Sun Pharma Site 7
Hilversum
Sun Pharma Site 2
Leeuwarden
Sun Pharma Site 8
Lelystad
Sun Pharma Site 10
Rotterdam
Sun Pharma Site 3
Rotterdam
Sun Pharma Site 5
Sneek
Sun Pharma Site 14
Uden
Sun pharma Site 01
Utrecht
Belgium8 sites
Sun Pharma Site 17
Brussels
Sun Pharma Site 18
Brussels
Sun Pharma Site 21
Brussels
Sun Pharma Site 22
Brussels
Sun Pharma Site 23
Brussels
Sun Pharma Site 16
Leuven
Sun Pharma Site 19
Liège
Sun Pharma Site 20
Merksem
About this study
This study is designated to evaluate the safety and efficacy of Sunpharma1505 in subjects with active rheumatoid arthritis who are experiencing a flare/exacerbation.
- Conditions
- Active Rheumatoid Arthritis
- Being tested
- Treatment I, Treatment II, Treatment III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment IDrug
Sunpharma1505 and Placebo
Treatment IIDrug
Sunpharma1505 and Placebo
Treatment IIIDrug
Reference1505 and Placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1: Sunpharma1505 (Low dose) and Placebo | Experimental | Not described Receives: Drug: Treatment I |
| Treatment II: Sunpharma1505 (High Dose) and Placebo | Experimental | Not described Receives: Drug: Treatment II |
| Treatment III: Reference1505 and Placebo | Active comparator | Not described Receives: Drug: Treatment III |
What is being measured
The primary outcome is the main question the study is designed to answer.
Good/Moderate European League Against Rheumatism Responders
Measured: week 1
Secondary outcomes (3)
Good European League Against Rheumatism -Responders
Measured: Day 8
Good/Moderate European League Against Rheumatism Responders
Measured: Day 15
Good European League Against Rheumatism Responders
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startNov 2015
- Primary completionMar 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Active Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Sun Pharmaceutical Industries LimitedThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534896
- Sponsor's protocol ID
- CLR_15_05
- Status last verified
- Nov 2021
- First submitted
- 25 Aug 2015
- Last updated
- 19 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02534896
- Acronym / sponsor ID
- CLR_15_05
- Conditions
- Active Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Mar 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 28 Aug 2015 (estimated)
- Results
- Posted 21 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designated to evaluate the safety and efficacy of Sunpharma1505 in subjects with active rheumatoid arthritis who are experiencing a flare/exacerbation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment 1: Sunpharma1505 (Low dose) and Placebo | Experimental | Drug: Treatment I |
| Treatment II: Sunpharma1505 (High Dose) and Placebo | Experimental | Drug: Treatment II |
| Treatment III: Reference1505 and Placebo | Active comparator | Drug: Treatment III |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects able and willing to give written informed consent and is available for entire study.
- Male or female ≥ 18 years old
- Willing and able to comply with the study protocol visits, assessments and accessible for follow up
- Known Diagnosed Rheumatoid arthritis
- Subjects of child bearing potential should be non-lactating and must be practicing an acceptable method of birth control as judged by the Investigator
Key exclusion criteria (5 listed)
- Subjects who are pregnant or intend to become pregnant during the study
- Subject with positive hepatitis panel and / or anti-hepatitis B core antibodies, and / or hepatitis C virus antibody [anti-HCV]), and / or a positive Human immunodeficiency virus (HIV) antibody.
- Known sensitivity to any component of the study drug or previous hypersensitivity reaction or other clinically significant reaction to IV medications, biologic therapy or IV radiocontrast agents.
- Active infection requiring systemic treatment
- Planned surgery during the study period or had undergone major surgery within the 60 Days prior to the Screening visit.
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 |
|---|---|---|
| Treatment ISunpharma1505 and Placebo | Drug | Treatment 1: Sunpharma1505 (Low dose) and Placebo |
| Treatment IISunpharma1505 and Placebo | Drug | Treatment II: Sunpharma1505 (High Dose) and Placebo |
| Treatment IIIReference1505 and Placebo | Drug | Treatment III: Reference1505 and Placebo |
Primary outcome
Good/Moderate European League Against Rheumatism Responders
Time frame: week 1
3 secondary outcomes
Good European League Against Rheumatism -Responders
Time frame: Day 8
Good/Moderate European League Against Rheumatism Responders
Time frame: Day 15
Good European League Against Rheumatism Responders
Time frame: Day 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Active Rheumatoid Arthritis
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.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Treatment I, Treatment II and Treatment III in people with Active Rheumatoid Arthritis, run by Sun Pharmaceutical Industries Limited at 20 sites in 2 countries.
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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Netherlands, Belgium. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Good/Moderate European League Against Rheumatism Responders (time frame: week 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 19 Nov 2021.