NCT01577264

Brief Summary

This is an observational trial in Rheumatoid Arthritis and Crohn's Disease patients treated with Cimzia aiming to evaluate the risk and incidence of Tuberculosis.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2011

Longer than P75 for all trials

Geographic Reach
1 country

45 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 13, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

November 10, 2015

Status Verified

November 1, 2015

Enrollment Period

4.2 years

First QC Date

April 11, 2012

Last Update Submit

November 9, 2015

Conditions

Rheumatoid ArthritisCrohn's Disease

Keywords

Certolizumab PegolCimzia

Outcome Measures

Primary Outcomes (1)

  • Incidence of Tuberculosis infection or reactivation during the study

    The incidence of Tuberculosis (TB) infection or reactivation is assessed by routine TB diagnostic tests (Chest X-ray, skin test, Interferon-γ-release assays recognizing antigens representing 2 Mycobacterium tuberculosis proteins (preferably both blood and skin tests), ESAT-6 and CFP-10)

    From Baseline to Week 156 (Visit 7)

Secondary Outcomes (13)

  • Change from Baseline in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 26

    From Baseline to Week 26 (Visit 2)

  • Change from Baseline in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 52

    From Baseline to Week 52 (Visit 3)

  • Change from Baseline in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 78

    From Baseline to Week 78 (Visit 4)

  • Change from Baseline in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 104

    From Baseline to Week 104 (Visit 5)

  • Change from Baseline in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 130

    From Baseline to Week 130 (Visit 6)

  • +8 more secondary outcomes

Study Arms (1)

Cimzia treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from previous UCB sponsored studies and all patients for whom the treating physician prescribed Cimzia.

You may qualify if:

  • Patients who have been prescribed Cimzia

You may not qualify if:

  • Any contra-indication according to the Russian Summary of Product Characteristic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (45)

12

Kazan', Russia

Location

16

Kazan', Russia

Location

11

Moscow, Russia

Location

14

Moscow, Russia

Location

24

Moscow, Russia

Location

25

Moscow, Russia

Location

31

Moscow, Russia

Location

34

Moscow, Russia

Location

36

Moscow, Russia

Location

40

Moscow, Russia

Location

42

Moscow, Russia

Location

45

Moscow, Russia

Location

5

Moscow, Russia

Location

7

Moscow, Russia

Location

8

Moscow, Russia

Location

9

Moscow, Russia

Location

20

Orenburg, Russia

Location

21

Orenburg, Russia

Location

29

Orenburg, Russia

Location

43

Perm, Russia

Location

39

Petrozavodzk, Russia

Location

19

Saint Petersburg, Russia

Location

1

Saint Petersburg, Russia

Location

3

Saint Petersburg, Russia

Location

4

Saint Petersburg, Russia

Location

6

Saint Petersburg, Russia

Location

15

Samara, Russia

Location

18

Samara, Russia

Location

41

Samara, Russia

Location

33

Saratov, Russia

Location

17

Shakhty, Russia

Location

10

Taganrog, Russia

Location

26

Tolyatti, Russia

Location

22

Ufa, Russia

Location

27

Ufa, Russia

Location

32

Ufa, Russia

Location

35

Ufa, Russia

Location

37

Ufa, Russia

Location

38

Ufa, Russia

Location

55

Ufa, Russia

Location

30

Ulyanovsk, Russia

Location

23

Veliky Novgorod, Russia

Location

2

Yaroslavl, Russia

Location

13

Yekaterinburg, Russia

Location

28

Yekaterinburg, Russia

Location

MeSH Terms

Conditions

Arthritis, RheumatoidCrohn Disease

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesInflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • UCB Clinical Trial Call Center

    +1 877 822 9493 (UCB)

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2012

First Posted

April 13, 2012

Study Start

August 1, 2011

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

November 10, 2015

Record last verified: 2015-11

Locations

RU(45)