MedDataX Logo

Certolizumab Pegol for the Treatment of Patients With Active Rheumatoid Arthritis (RA) and Crohn's Disease (CD)

NCT ID: NCT01577264

Last Updated: 2015-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

199 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2015-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Evaluate Safety of Long Term Therapy of Certolizumab Pegol Patients With Crohn's Disease

NCT00552344

Crohn Disease
COMPLETED PHASE3

Optimizing Cimzia in Crohn's Patients

NCT01024647

Crohn's Disease
UNKNOWN PHASE4

Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease

NCT00552058

Crohn Disease
COMPLETED PHASE3

Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab

NCT00308581

Crohn's Disease
COMPLETED PHASE3

Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease

NCT00291668

Crohn's Disease
COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a prospective non interventional study. Patients enrolled in this study will receive Cimzia on prescription according to the instructions for use approved in Russia and within the frame of current standard clinical practices. The patient is evaluated at the Screening Visit for enrollment. A Baseline Visit is to be scheduled no more than 28 days after the Screening Visit. Subsequent evaluations are done routinely every 6 months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatoid Arthritis Crohn's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cimzia treatment

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients who have been prescribed Cimzia

Exclusion Criteria

* Any contra-indication according to the Russian Summary of Product Characteristic
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

UCB Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

12

Kazan', , Russia

Site Status

16

Kazan', , Russia

Site Status

11

Moscow, , Russia

Site Status

14

Moscow, , Russia

Site Status

24

Moscow, , Russia

Site Status

25

Moscow, , Russia

Site Status

31

Moscow, , Russia

Site Status

34

Moscow, , Russia

Site Status

36

Moscow, , Russia

Site Status

40

Moscow, , Russia

Site Status

42

Moscow, , Russia

Site Status

45

Moscow, , Russia

Site Status

5

Moscow, , Russia

Site Status

7

Moscow, , Russia

Site Status

8

Moscow, , Russia

Site Status

9

Moscow, , Russia

Site Status

20

Orenburg, , Russia

Site Status

21

Orenburg, , Russia

Site Status

29

Orenburg, , Russia

Site Status

43

Perm, , Russia

Site Status

39

Petrozavodzk, , Russia

Site Status

19

Saint Petersburg, , Russia

Site Status

1

Saint Petersburg, , Russia

Site Status

3

Saint Petersburg, , Russia

Site Status

4

Saint Petersburg, , Russia

Site Status

6

Saint Petersburg, , Russia

Site Status

15

Samara, , Russia

Site Status

18

Samara, , Russia

Site Status

41

Samara, , Russia

Site Status

33

Saratov, , Russia

Site Status

17

Shakhty, , Russia

Site Status

10

Taganrog, , Russia

Site Status

26

Tolyatti, , Russia

Site Status

22

Ufa, , Russia

Site Status

27

Ufa, , Russia

Site Status

32

Ufa, , Russia

Site Status

35

Ufa, , Russia

Site Status

37

Ufa, , Russia

Site Status

38

Ufa, , Russia

Site Status

55

Ufa, , Russia

Site Status

30

Ulyanovsk, , Russia

Site Status

23

Veliky Novgorod, , Russia

Site Status

2

Yaroslavl, , Russia

Site Status

13

Yekaterinburg, , Russia

Site Status

28

Yekaterinburg, , Russia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Russia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RA0091

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

EUS Evaluation of Perianal and Peri-rectal Fistulizing Crohn's Disease With CERTOLIZUMAB Treatment
NCT01582568 TERMINATED
A Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug (Placebo)
NCT00152490 COMPLETED PHASE3
Study of Cimzia for the Treatment of Ulcerative Colitis
NCT01090154 COMPLETED PHASE2
Mucosal Healing Study in Crohn's Disease (CD)
NCT00297648 COMPLETED PHASE3
Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease
NCT00349752 TERMINATED PHASE3
Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug (Placebo), Following 3 Doses of Active Drug (CDP870).
NCT00152425 COMPLETED PHASE3
Evaluate Efficacy of Certolizumab in Crohn's Patients With Draining Fistulas
NCT00354367 WITHDRAWN PHASE3
A follow-on Safety Study of CDP870 in Subjects With Crohn's Disease (CD) Who Have Completed a 26-week Double Blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425]
NCT00160524 COMPLETED PHASE3
Certolizumab Pegol for Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Failed Infliximab
NCT00307931 TERMINATED PHASE3
Maintenance Study of Certolizumab Pegol (CZP) in Crohn's Disease
NCT00329550 COMPLETED PHASE2
CUP Certolizumab Pegol (CDP-870) in Adults Suffering From Crohn's Disease (CD)
NCT03559660 NO_LONGER_AVAILABLE
A Study to Test Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Crohn's Disease
NCT04643483 WITHDRAWN PHASE3
Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol
NCT01190410 COMPLETED PHASE2
Follow-up to Welcome Study C87042 [NCT00308581] Examining Certolizumab Pegol (CDP870) in Subjects With Crohn's Disease
NCT00333788 COMPLETED PHASE3
Maintenance Study Including Re-induction Therapy for Patients Who Did Not Show a Clinical Effect in Study C87037 (NCT00291668)
NCT00329420 COMPLETED PHASE2
Cimzia Versus Cimzia Plus Azathioprine in the Treatment of Active Crohn's Disease
NCT01817972 UNKNOWN PHASE3
Examining the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's Disease
NCT00356408 COMPLETED PHASE3
A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease
NCT05347095 ACTIVE_NOT_RECRUITING PHASE3
A follow-on Safety Study in Subjects With Crohn's Disease Who Have Previously Been Withdrawn From the Double-blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] Due to an Exacerbation of Crohn's Disease
NCT00160706 COMPLETED PHASE3
Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144
NCT02403323 TERMINATED PHASE3
Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease or Ulcerative Colitis
NCT03169894 TERMINATED PHASE1
A Trial Evaluating Safety of Chronic Therapy With Certolizumab Pegol in Crohn's Disease
NCT00358683 WITHDRAWN PHASE3
A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease
NCT03105102 ACTIVE_NOT_RECRUITING PHASE3
Observational Study of Disease Severity in Participants Diagnosed With Crohn's Disease and Long Term Impact of Treatment Strategies in Participants With Moderate to Severe Crohn's Disease (Protocol P06484)
NCT01218360 COMPLETED
A Study to Learn About the Study Medicine Called Infliximab (Genetical Recombination)[Infliximab Biosimilar 3] in People With Rheumatoid Arthritis, Ulcerative Colitis, Crohn's Disease, or Psoriasis
NCT05796245 COMPLETED