Use of Tocilizumab for Rheumatoid Arthritis (RA) in Daily Routine

Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Tocilizumab for the Treatment of Rheumatoid Arthritis: Findings on The Use of Tocilizumab in Daily Clinical Routine

ClinicalTrials.gov ID

NCT02809833

Acronym / sponsor ID

ML22734

Conditions

Rheumatoid Arthritis

Study type

Observational

Recruitment status

Completed

Enrolment

850 participants (actual)

Lead sponsor

Hoffmann-La RocheIndustry (pharma, biotech, devices)

Study start

Jan 2009

Primary completion

Mar 2012 (actual)

Study completion

Mar 2012 (actual)

First posted

22 Jun 2016 (estimated)

Results

Posted 24 Oct 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Prospective

Number of arms

1

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Study population

Participants from routine clinical practice in Germany who are receiving tocilizumab for RA according to SmPC are eligible.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Percentage of Participants With Categorized Laboratory Data Available at Baseline

   Time frame: Baseline

   SmPC recommendations were specified in the collection of routine laboratory samples for alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), absolute neutrophil count (ANC), and low platelet count to guide dose decisions. Laboratory values for ALAT and ASAT were to be categorized in reference to the institution-specific upper limit of normal (ULN). Laboratory values for ANC and platelet count were to be categorized in reference to a normal range outlined in the SmPC. This range was 0.5 to 1 × 10^9 cells per liter (cells/L) for ANC and 50 to 100 × 10^3 cells per microliter (cells/μL) for platelet count. The percentage of participants with greater than or equal to (≥) 1 documented/evaluable laboratory value at Baseline was reported, along with the percentage of participants with categorized laboratory data available for each individual parameter.

2. Percentage of Participants With Categorized Laboratory Data Available at Week 24

   Time frame: Week 24

   SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and low platelet count to guide dose decisions. Laboratory values for ALAT and ASAT were to be categorized in reference to the institution-specific ULN. Laboratory values for ANC and platelet count were to be categorized in reference to a normal range outlined in the SmPC. This range was 0.5 to 1 × 10^9 cells/L for ANC and 50 to 100 × 10^3 cells/μL for platelet count. The percentage of participants with ≥1 documented/evaluable laboratory value at Week 24 was reported, along with the percentage of participants with categorized laboratory data available for each individual parameter.

3. Percentage of Participants With Categorized Laboratory Data Available at Week 52

   Time frame: Week 52

   SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and low platelet count to guide dose decisions. Laboratory values for ALAT and ASAT were to be categorized in reference to the institution-specific ULN. Laboratory values for ANC and platelet count were to be categorized in reference to a normal range outlined in the SmPC. This range was 0.5 to 1 × 10^9 cells/L for ANC and 50 to 100 × 10^3 cells/μL for platelet count. The percentage of participants with ≥1 documented/evaluable laboratory value at Week 52 was reported, along with the percentage of participants with categorized laboratory data available for each individual parameter.

4. Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4

   Time frame: Week 4

   SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values greater than (>) 1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC less than (<) 0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with ("Yes") or without ("No") tocilizumab dose adjustment or interruption was reported at Week 4.

5. Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8

   Time frame: Week 8

   SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with ("Yes") or without ("No") tocilizumab dose adjustment or interruption was reported at Week 8.

6. Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12

   Time frame: Week 12

   SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with ("Yes") or without ("No") tocilizumab dose adjustment or interruption was reported at Week 12.

7. Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16

   Time frame: Week 16

   SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with ("Yes") or without ("No") tocilizumab dose adjustment or interruption was reported at Week 16.

8. Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20

   Time frame: Week 20

   SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with ("Yes") or without ("No") tocilizumab dose adjustment or interruption was reported at Week 20.

9. Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24

   Time frame: Week 24

   SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with ("Yes") or without ("No") tocilizumab dose adjustment or interruption was reported at Week 24.

10. Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28

    Time frame: Week 28

    SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with ("Yes") or without ("No") tocilizumab dose adjustment or interruption was reported at Week 28.

11. Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32

    Time frame: Week 32

    SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with ("Yes") or without ("No") tocilizumab dose adjustment or interruption was reported at Week 32.

12. Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36

    Time frame: Week 36

    SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with ("Yes") or without ("No") tocilizumab dose adjustment or interruption was reported at Week 36.

13. Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40

    Time frame: Week 40

    SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with ("Yes") or without ("No") tocilizumab dose adjustment or interruption was reported at Week 40.

14. Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44

    Time frame: Week 44

    SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with ("Yes") or without ("No") tocilizumab dose adjustment or interruption was reported at Week 44.

15. Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48

    Time frame: Week 48

    SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with ("Yes") or without ("No") tocilizumab dose adjustment or interruption was reported at Week 48.

16. Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52

    Time frame: Week 52

    SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with ("Yes") or without ("No") tocilizumab dose adjustment or interruption was reported at Week 52.

17. Percentage of Participants With Tocilizumab Dose Adjustments by Reason

    Time frame: Baseline to end of treatment (up to 12 months)

    The percentage of participants with any tocilizumab dose adjustment during the study was reported among all reasons given for tocilizumab dose adjustments, as provided in the CRF. The sum of all reasons may add up to >100 percent (%) because more than one reason could be given for each dose change. In the table presented, "Other Reasons" refers to any reason other than those specified in categories. Similarly, "Other Laboratory Change" refers to a change in any laboratory parameter other than those specified in categories.

18. 28-Joint Disease Activity Score (DAS28) at Baseline

    Time frame: Baseline

    The DAS28 was derived from assessments of erythrocyte sedimentation rate (ESR), tender joint count (TJC), swollen joint count (SJC), and general health according to 100-millimeter (mm) Visual Analog Scale (VAS). DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in millimeters per hour (mm/h). DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The score at Baseline was reported.

19. Change in DAS28 From Baseline to Week 4

    Time frame: Baseline to Week 4

    The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 4 was reported, where negative changes indicated an improvement in disease activity.

20. Change in DAS28 From Baseline to Week 8

    Time frame: Baseline to Week 8

    The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 8 was reported, where negative changes indicated an improvement in disease activity.

21. Change in DAS28 From Baseline to Week 12

    Time frame: Baseline to Week 12

    The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 12 was reported, where negative changes indicated an improvement in disease activity.

22. Change in DAS28 From Baseline to Week 16

    Time frame: Baseline to Week 16

    The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 16 was reported, where negative changes indicated an improvement in disease activity.

23. Change in DAS28 From Baseline to Week 20

    Time frame: Baseline to Week 20

    The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 20 was reported, where negative changes indicated an improvement in disease activity.

24. Change in DAS28 From Baseline to Week 24

    Time frame: Baseline to Week 24

    The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 24 was reported, where negative changes indicated an improvement in disease activity.

25. Change in DAS28 From Baseline to Week 28

    Time frame: Baseline to Week 28

    The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 28 was reported, where negative changes indicated an improvement in disease activity.

26. Change in DAS28 From Baseline to Week 32

    Time frame: Baseline to Week 32

    The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 32 was reported, where negative changes indicated an improvement in disease activity.

27. Change in DAS28 From Baseline to Week 36

    Time frame: Baseline to Week 36

    The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 36 was reported, where negative changes indicated an improvement in disease activity.

28. Change in DAS28 From Baseline to Week 40

    Time frame: Baseline to Week 40

    The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 40 was reported, where negative changes indicated an improvement in disease activity.

29. Change in DAS28 From Baseline to Week 44

    Time frame: Baseline to Week 44

    The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 44 was reported, where negative changes indicated an improvement in disease activity.

30. Change in DAS28 From Baseline to Week 48

    Time frame: Baseline to Week 48

    The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 48 was reported, where negative changes indicated an improvement in disease activity.

31. Change in DAS28 From Baseline to Week 52

    Time frame: Baseline to Week 52

    The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 52 was reported, where negative changes indicated an improvement in disease activity.

32. TJC at Baseline

    Time frame: Baseline

    A total of 28 joints were assessed for tenderness. The number of tender joints at Baseline was reported and could range from 0 to 28, where higher values represented more tender joints.

33. Change in TJC From Baseline to Week 12

    Time frame: Baseline to Week 12

    A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to Week 12 was reported, where negative changes indicated an improvement in disease activity.

34. Change in TJC From Baseline to Week 24

    Time frame: Baseline to Week 24

    A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to Week 24 was reported, where negative changes indicated an improvement in disease activity.

35. Change in TJC From Baseline to Week 36

    Time frame: Baseline to Week 36

    A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to Week 36 was reported, where negative changes indicated an improvement in disease activity.

36. Change in TJC From Baseline to Week 52

    Time frame: Baseline to Week 52

    A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to Week 52 was reported, where negative changes indicated an improvement in disease activity.

37. SJC at Baseline

    Time frame: Baseline

    A total of 28 joints were assessed for swollenness. The number of swollen joints at Baseline was reported and could range from 0 to 28, where higher values represented more swollen joints.

38. Change in SJC From Baseline to Week 12

    Time frame: Baseline to Week 12

    A total of 28 joints were assessed for swollenness. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to Week 12 was reported, where negative changes indicated an improvement in disease activity.

39. Change in SJC From Baseline to Week 24

    Time frame: Baseline to Week 24

    A total of 28 joints were assessed for swollenness. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to Week 24 was reported, where negative changes indicated an improvement in disease activity.

40. Change in SJC From Baseline to Week 36

    Time frame: Baseline to Week 36

    A total of 28 joints were assessed for swollenness. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to Week 36 was reported, where negative changes indicated an improvement in disease activity.

41. Change in SJC From Baseline to Week 52

    Time frame: Baseline to Week 52

    A total of 28 joints were assessed for swollenness. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to Week 52 was reported, where negative changes indicated an improvement in disease activity.

42. VAS Score of Participant-Assessed Disease Activity at Baseline

    Time frame: Baseline

    Participant-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The VAS score at Baseline was reported.

43. Change in VAS Score of Participant-Assessed Disease Activity From Baseline to Week 12

    Time frame: Baseline to Week 12

    Participant-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 12 was reported, where negative changes indicated a decrease in participant-assessed disease activity.

44. Change in VAS Score of Participant-Assessed Disease Activity From Baseline to Week 24

    Time frame: Baseline to Week 24

    Participant-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 24 was reported, where negative changes indicated a decrease in participant-assessed disease activity.

45. Change in VAS Score of Participant-Assessed Disease Activity From Baseline to Week 36

    Time frame: Baseline to Week 36

    Participant-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 36 was reported, where negative changes indicated a decrease in participant-assessed disease activity.

46. Change in VAS Score of Participant-Assessed Disease Activity From Baseline to Week 52

    Time frame: Baseline to Week 52

    Participant-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 52 was reported, where negative changes indicated a decrease in participant-assessed disease activity.

47. VAS Score of Physician-Assessed Disease Activity at Baseline

    Time frame: Baseline

    Physician-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The VAS score at Baseline was reported.

48. Change in VAS Score of Physician-Assessed Disease Activity From Baseline to Week 12

    Time frame: Baseline to Week 12

    Physician-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 12 was reported, where negative changes indicated a decrease in physician-assessed disease activity.

49. Change in VAS Score of Physician-Assessed Disease Activity From Baseline to Week 24

    Time frame: Baseline to Week 24

    Physician-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 24 was reported, where negative changes indicated a decrease in physician-assessed disease activity.

50. Change in VAS Score of Physician-Assessed Disease Activity From Baseline to Week 36

    Time frame: Baseline to Week 36

    Physician-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 36 was reported, where negative changes indicated a decrease in physician-assessed disease activity.

51. Change in VAS Score of Physician-Assessed Disease Activity From Baseline to Week 52

    Time frame: Baseline to Week 52

    Physician-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 52 was reported, where negative changes indicated a decrease in physician-assessed disease activity.

52. Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 4

    Time frame: Baseline to Week 4

    Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 4 visit and the DAS28 change from Baseline to Week 4. Participants with a score less than or equal to (≤) 3.2 and reduction of >1.2 points were assessed as having a "Good" response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a "Moderate" response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as "No Improvement".

53. Percentage of Participants With EULAR Response at Week 12

    Time frame: Baseline to Week 12

    Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 12 visit and the DAS28 change from Baseline to Week 12. Participants with a score ≤3.2 and reduction of >1.2 points were assessed as having a "Good" response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a "Moderate" response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as "No Improvement".

54. Percentage of Participants With EULAR Response at Week 24

    Time frame: Baseline to Week 24

    Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 24 visit and the DAS28 change from Baseline to Week 24. Participants with a score ≤3.2 and reduction of >1.2 points were assessed as having a "Good" response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a "Moderate" response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as "No Improvement".

55. Percentage of Participants With EULAR Response at Week 36

    Time frame: Baseline to Week 36

    Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 36 visit and the DAS28 change from Baseline to Week 36. Participants with a score ≤3.2 and reduction of >1.2 points were assessed as having a "Good" response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a "Moderate" response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as "No Improvement".

56. Percentage of Participants With EULAR Response at Week 52

    Time frame: Baseline to Week 52

    Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 52 visit and the DAS28 change from Baseline to Week 52. Participants with a score ≤3.2 and reduction of >1.2 points were assessed as having a "Good" response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a "Moderate" response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as "No Improvement".

57. Percentage of Participants With Low Disease Activity Score (LDAS) According to DAS28 at Baseline

    Time frame: Baseline

    The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Baseline.

58. Percentage of Participants With LDAS According to DAS28 at Week 12

    Time frame: Week 12

    The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Week 12.

59. Percentage of Participants With LDAS According to DAS28 at Week 24

    Time frame: Week 24

    The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Week 24.

60. Percentage of Participants With LDAS According to DAS28 at Week 36

    Time frame: Week 36

    The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Week 36.

61. Percentage of Participants With LDAS According to DAS28 at Week 52

    Time frame: Week 52

    The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Week 52.

62. Percentage of Participants With Remission According to DAS28 at Baseline

    Time frame: Baseline

    The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score <2.6 at Baseline.

63. Percentage of Participants With Remission According to DAS28 at Week 12

    Time frame: Week 12

    The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score <2.6 at Week 12.

64. Percentage of Participants With Remission According to DAS28 at Week 24

    Time frame: Week 24

    The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score <2.6 at Week 24.

65. Percentage of Participants With Remission According to DAS28 at Week 36

    Time frame: Week 36

    The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score <2.6 at Week 36.

66. Percentage of Participants With Remission According to DAS28 at Week 52

    Time frame: Week 52

    The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score <2.6 at Week 52.

67. Percentage of Participants With Minimum Clinically Important Improvement (MCII) According to DAS28 at Week 12

    Time frame: Baseline to Week 12

    The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. MCII was defined as DAS28 reduction of ≥1.2 points from Baseline to Week 12.

68. Percentage of Participants With MCII According to DAS28 at Week 24

    Time frame: Baseline to Week 24

    The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. MCII was defined as DAS28 reduction of ≥1.2 points from Baseline to Week 24.

69. Percentage of Participants With MCII According to DAS28 at Week 36

    Time frame: Baseline to Week 36

    The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. MCII was defined as DAS28 reduction of ≥1.2 points from Baseline to Week 36.

70. Percentage of Participants With MCII According to DAS28 at Week 52

    Time frame: Baseline to Week 52

    The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. MCII was defined as DAS28 reduction of ≥1.2 points from Baseline to Week 52.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

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