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TerminatedNCT02534896Updated Nov 19, 2021Results posted

To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis

A Phase 3 interventional study of Treatment I and Treatment II in Active Rheumatoid Arthritis, sponsored by Sun Pharmaceutical Industries Limited. Terminated at 20 sites in 2 countries. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-11-19.

Sponsored by Sun Pharmaceutical Industries Limited · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Active Rheumatoid Arthritis
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 150 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Sun Pharmaceutical Industries Limited is the lead sponsor of 58 studies on the registry; 5 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 22 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subjects able and willing to give written informed consent and is available for entire study.
  2. Male or female ≥ 18 years old
  3. Willing and able to comply with the study protocol visits, assessments and accessible for follow up
  4. Known Diagnosed Rheumatoid arthritis
  5. Subjects of child bearing potential should be non-lactating and must be practicing an acceptable method of birth control as judged by the Investigator

Exclusion criteria

Exclusion Criteria:

  1. Subjects who are pregnant or intend to become pregnant during the study
  2. 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.
  3. 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.
  4. Active infection requiring systemic treatment
  5. Planned surgery during the study period or had undergone major surgery within the 60 Days prior to the Screening visit.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    Treatment 1: Sunpharma1505 (Low dose) and Placebo

    Drug: Treatment I

  • Experimental
    Treatment II: Sunpharma1505 (High Dose) and Placebo

    Drug: Treatment II

  • Active comparator
    Treatment III: Reference1505 and Placebo

    Drug: Treatment III

Interventions

  • DrugTreatment I

    Sunpharma1505 and Placebo

  • DrugTreatment II

    Sunpharma1505 and Placebo

  • DrugTreatment III

    Reference1505 and Placebo

06

What researchers measure

Primary outcomes

  1. Good/Moderate European League Against Rheumatism Responders

    Time frame: week 1

Secondary outcomes

  1. Good European League Against Rheumatism -Responders

    Time frame: Day 8

  2. Good/Moderate European League Against Rheumatism Responders

    Time frame: Day 15

  3. Good European League Against Rheumatism Responders

    Time frame: Day 15

07

Results

Posted Nov 21, 2019

Participant flow

Participant flow — Overall Study
MilestoneTreatment I : Sunpharma1505 (Low Dose) and PlaceboTreatment II: Sunpharma1505 (High Dose) and PlaceboTreatment III: Reference1505 and Placebo
Started495249
Completed455148
Not completed411
Withdrew: Adverse event211
Withdrew: Insufficient therapeutic response200

Outcome measures

PrimaryGood/Moderate European League Against Rheumatism Responders
Time frame:
week 1
Reported as:
Count of participants · Participants
Good/Moderate European League Against Rheumatism Responders
ParticipantsTreatment I : Sunpharma1505 (Low Dose) and PlaceboTreatment II: Sunpharma1505 (High Dose) and PlaceboTreatment III: Reference1505 and Placebo
Good/Moderate European League Against Rheumatism Responders424532
Statistical analysis
  • Treatment I : Sunpharma1505 (Low Dose) and Placebo vs Treatment III: Reference1505 and Placebo · Hochberg and Gatekeeping · p = 0.018
  • Treatment II: Sunpharma1505 (High Dose) and Placebo vs Treatment III: Reference1505 and Placebo · Hochberg and Gatekeeping · p = 0.007
SecondaryGood European League Against Rheumatism -Responders
Time frame:
Day 8
Reported as:
Count of participants · Participants
Good European League Against Rheumatism -Responders
ParticipantsTreatment I : Sunpharma1505 (Low Dose) and PlaceboTreatment II: Sunpharma1505 (High Dose) and PlaceboTreatment III: Reference1505 and Placebo
Good European League Against Rheumatism -Responders212610
Statistical analysis
  • Treatment I : Sunpharma1505 (Low Dose) and Placebo vs Treatment III: Reference1505 and Placebo · Hochberg and Gatekeeping · p = 0.028
  • Treatment II: Sunpharma1505 (High Dose) and Placebo vs Treatment III: Reference1505 and Placebo · Hochberg and Gatekeeping · p = 0.003
SecondaryGood/Moderate European League Against Rheumatism Responders
Time frame:
Day 15
Reported as:
Count of participants · Participants
Good/Moderate European League Against Rheumatism Responders
ParticipantsTreatment I : Sunpharma1505 (Low Dose) and PlaceboTreatment II: Sunpharma1505 (High Dose) and PlaceboTreatment III: Reference1505 and Placebo
Good/Moderate European League Against Rheumatism Responders424342
Statistical analysis
  • Treatment I : Sunpharma1505 (Low Dose) and Placebo vs Treatment III: Reference1505 and Placebo · Hochberg and Gatekeeping · p = 0.960
  • Treatment II: Sunpharma1505 (High Dose) and Placebo vs Treatment III: Reference1505 and Placebo · Hochberg and Gatekeeping · p = 0.339
SecondaryGood European League Against Rheumatism Responders
Time frame:
Day 15
Reported as:
Count of participants · Participants
Good European League Against Rheumatism Responders
ParticipantsTreatment I : Sunpharma1505 (Low Dose) and PlaceboTreatment II: Sunpharma1505 (High Dose) and PlaceboTreatment III: Reference1505 and Placebo
Good European League Against Rheumatism Responders243321
Statistical analysis
  • Treatment I : Sunpharma1505 (Low Dose) and Placebo vs Treatment III: Reference1505 and Placebo · Hochberg and Gatekeeping · p = 0.573
  • Treatment II: Sunpharma1505 (High Dose) and Placebo vs Treatment III: Reference1505 and Placebo · Hochberg and Gatekeeping · p = 0.374

Adverse events

Collected over Week 12. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment I: Sunpharma1505 (Low Dose) and Placebo0/49 (0%)4/49 (8.2%)42/49 (85.7%)
Treatment II: Sunpharma1505 (High Dose) and Placebo0/52 (0%)1/52 (1.9%)46/52 (88.5%)
Treatment III: Reference1505 and Placebo0/49 (0%)2/49 (4.1%)39/49 (79.6%)
Most frequent serious events
Most frequent serious events
EventTreatment I: Sunpharma1505 (Low Dose) and PlaceboTreatment II: Sunpharma1505 (High Dose) and PlaceboTreatment III: Reference1505 and Placebo
Infusion related reactionInjury, poisoning and procedural complications1/490/520/49
Neuroendocrine carcinoma of the skinNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/490/521/49
HypersensitivityImmune system disorders1/491/520/49
VomitingGastrointestinal disorders1/490/520/49
DehydrationMetabolism and nutrition disorders1/490/520/49
Viral upper respiratory tract infectionInfections and infestations0/490/521/49
Most frequent other events
Most frequent other events
EventTreatment I: Sunpharma1505 (Low Dose) and PlaceboTreatment II: Sunpharma1505 (High Dose) and PlaceboTreatment III: Reference1505 and Placebo
NauseaGastrointestinal disorders9/496/521/49
HeadacheNervous system disorders8/499/526/49
Hot flushVascular disorders4/496/526/49
FatigueGeneral disorders6/496/525/49
NasopharyngitisInfections and infestations6/495/524/49
HyeprhidrosisSkin and subcutaneous tissue disorders1/496/523/49
CoughRespiratory, thoracic and mediastinal disorders4/492/524/49
DizzinessNervous system disorders4/492/522/49
Back painMusculoskeletal and connective tissue disorders2/493/524/49
InfluenzaInfections and infestations3/492/520/49

Baseline characteristics

Age, Continuous
Age, Continuous(years)Treatment I: Sunpharma1505 (Low Dose) and PlaceboTreatment II: Sunpharma1505 (High Dose) and PlaceboTreatment III: Reference1505 and PlaceboTotal
Mean55.3 ± 13.7956.4 ± 10.7456.7 ± 11.1856.1 ± 11.89
Sex: Female, Male
Sex: Female, Male(Participants)Treatment I: Sunpharma1505 (Low Dose) and PlaceboTreatment II: Sunpharma1505 (High Dose) and PlaceboTreatment III: Reference1505 and PlaceboTotal
Female384235115
Male11101435
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Treatment I: Sunpharma1505 (Low Dose) and PlaceboTreatment II: Sunpharma1505 (High Dose) and PlaceboTreatment III: Reference1505 and PlaceboTotal
American Indian or Alaska Native0000
Asian1113
Native Hawaiian or Other Pacific Islander0000
Black or African American1124
White464943138
More than one race1135
Unknown or Not Reported0000
08

Study locations

20 sites
  • Sun Pharma Site 17
    Brussels, Belgium
  • Sun Pharma Site 18
    Brussels, Belgium
  • Sun Pharma Site 21
    Brussels, Belgium
  • Sun Pharma Site 22
    Brussels, Belgium
  • Sun Pharma Site 23
    Brussels, Belgium
  • Sun Pharma Site 16
    Leuven, Belgium
  • Sun Pharma Site 19
    Liege, Belgium
  • Sun Pharma Site 20
    Merksem, Belgium
  • Sun Pharma Site 11
    Amsterdam, Netherlands
  • Sun Pharma Site 9
    Amsterdam, Netherlands
  • Sun Pharma Site 6
    Enschede, Netherlands
  • Sun Pharma Site 4
    Heerlen, Netherlands
  • Sun Pharma Site 7
    Hilversum, Netherlands
  • Sun Pharma Site 2
    Leeuwarden, Netherlands
  • Sun Pharma Site 8
    Lelystad, Netherlands
  • Sun Pharma Site 10
    Rotterdam, Netherlands
  • Sun Pharma Site 3
    Rotterdam, Netherlands
  • Sun Pharma Site 5
    Sneek, Netherlands
  • Sun Pharma Site 14
    Uden, Netherlands
  • Sun pharma Site 01
    Utrecht, Netherlands
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jun 7, 2018

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02534896
Lead sponsor
Sun Pharmaceutical Industries Limited
Responsible party
Sponsor
First posted
Aug 28, 2015
Start date
Nov 2015
Primary completion
Mar 2018
Completion
Jun 2018
Results posted
Nov 21, 2019
Last update
Nov 19, 2021

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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