Follow-up of Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study

NCT ID: NCT00843778

Last Updated: 2014-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2012-12-31

Brief Summary

To continue to assess the clinical safety and efficacy of Certolizumab Pegol as add-on therapy with stable-dose Disease Modifying Anti-Rheumatic Drugs (DMARDs)

Detailed Description

This is a Phase IIIB, multi-centre, open-label, follow-up study to study C87076 [NCT00674362] designed to continue to assess the safety and efficacy of Certolizumab Pegol.

Two different population will enter the study from C87076 [NCT00674362] and will be treated with Certolizumab Pegol every two weeks until it is commercially available for the indication of Rheumatoid Arthritis (RA) in the subject's country or region or until further notice from UCB:

Population 1: Are those subjects who failed to achieve remission at Week 20 and/or Week 24 and who completed the Week 24 assessment of study C86076 [NCT00674362].The Week 24 assessment (visit 14) of C87076 [NCT00674362] will also be the entry assessment (visit 1) for C87080. The subjects will receive Certolizumab Pegol 200 mg every two weeks. No induction period will be applied to ensure the blinding of study C87076 [NCT00674362].

Population 2: Are those subjects who achieved remission at both Week 20 and Week 24, flared up between Week 24 and Week 52 and completed the Week 52 assessment in study C87076 [NCT00674362]. The Week 52 assessment (visit 26) of C87076 [NCT00674362] will also be the entry assessment (visit 1) for C87080.

Subjects who flared prior to Week 48 in the C87076 [NCT00674362] study will receive Certolizumab Pegol 200 mg every two weeks in the C87080 study.

Those who flared at Week 48 or Week 52, will receive respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject enters the C87080 study and will be further treated with 200 mg Certolizumab Pegol every two weeks.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Certolizumab Pegol

Certolizumab Pegol 200 mg every two weeks at the hospital by a nurse. Certolizumab Pegol 200 mg every two weeks at the patient's home done by patient (self-injection).

Group Type: EXPERIMENTAL

Certolizumab Pegol

Intervention Type: BIOLOGICAL

200 mg every two weeks

Certolizuimab Pegol 200 mg every two weeks Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], will receive respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject enters the C87080 study and will be further treated with 200 mg Certolizumab Pegol every two weeks.

Interventions

Certolizumab Pegol

200 mg every two weeks

Certolizuimab Pegol 200 mg every two weeks Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], will receive respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject enters the C87080 study and will be further treated with 200 mg Certolizumab Pegol every two weeks.

Intervention Type: BIOLOGICAL

Other Intervention Names

Cimzia; CDP870

Eligibility Criteria

Inclusion Criteria

• Patients with established adult rheumatoid arthritis on Disease Modifying Anti-Rheumatic Drugs (DMARDs) therapy who were included in C87076 protocol and:
• either failed to achieve remission after 6 months of study treatment
• or flared after the 6 months of study treatment and completed the study (C87076 [NCT00674362])

Exclusion Criteria

• All the concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment
• Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

6

Vienna, , Austria

11

Rennes, , France

64

Toulouse, , France

10

Tours, , France

17

Berlin, , Germany

47

Berlin, , Germany

20

Erlangen, , Germany

50

Essen, , Germany

16

Frankfurt, , Germany

19

Heidelberg, , Germany

15

Herne, , Germany

24

Ratingen, , Germany

18

Vogelsang-Gommern, , Germany

23

Würzburg, , Germany

29

Pavia, , Italy

34

Roma, , Italy

58

Bydgoszcz, , Poland

67

Elblag, , Poland

62

Lublin, , Poland

55

Poznan, , Poland

65

Poznan, , Poland

60

Sopot, , Poland

57

Szczecin, , Poland

69

Torun, , Poland

53

Warsaw, , Poland

Countries

Austria; France; Germany; Italy; Poland

Related Links

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

2007-000830-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C87080

Identifier Type: -

Identifier Source: org_study_id