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

NCT00843778 | Completed Phase 3 Results

• 2 other identifiers: C870802007-000830-38
• Study Type: interventional
• Target: 131
• Locations: 5 countries
• Sites: 25

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)

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; Moderate to Low Disease Activity; Certolizumab Pegol

Outcome Measures

Primary Outcomes (2)

• Percentage of Subjects Reporting At Least One Treatment-emergent Adverse Event (TEAE) During The Study Period

  A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases. A TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design). TEAEs are all AEs in which the onset and time is after the first study drug administration in C87080, up to 70 days after the last injection.

  From Entry Visit up to approximately 144 weeks

• Percentage of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) During The Study Period

  A Serious Adverse Event is any untoward medical occurrence that at any dose results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity is a congenital anomaly/birth defect.

  From Entry Visit up to approximately 144 weeks

Secondary Outcomes (28)

• Percentage of Subjects With DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Completion/Withdrawal Visit

  Completion/Withdrawal Visit (up to approximately Week 136)

• Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Completion/Withdrawal Visit

  Completion/Withdrawal Visit (up to approximately Week 136)

• Percentage of Subjects With SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Completion/Withdrawal Visit

  Completion/Withdrawal Visit (up to approximately Week 136)

• Percentage of Subjects With ACR20 (American College of Rheumatology 20 % Improvement) Response at Completion/Withdrawal Visit

  Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)

• Percentage of Subjects With ACR50 (American College of Rheumatology 50 % Improvement) Response at Completion/Withdrawal Visit

  Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)

Study Arms (1)

Certolizumab Pegol

EXPERIMENTAL

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).

Biological: Certolizumab Pegol

Interventions

Certolizumab Pegol 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.

Also known as: Cimzia, CDP870

Certolizumab Pegol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[NCT00674362\])

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (25)

6

Vienna, Austria

Location

11

Rennes, France

Location

64

Toulouse, France

Location

10

Tours, France

Location

17

Berlin, Germany

Location

47

Berlin, Germany

Location

20

Erlangen, Germany

Location

50

Essen, Germany

Location

16

Frankfurt, Germany

Location

19

Heidelberg, Germany

Location

15

Herne, Germany

Location

24

Ratingen, Germany

Location

18

Vogelsang-Gommern, Germany

Location

23

Würzburg, Germany

Location

29

Pavia, Italy

Location

34

Roma, Italy

Location

58

Bydgoszcz, Poland

Location

67

Elblag, Poland

Location

62

Lublin, Poland

Location

55

Poznan, Poland

Location

65

Poznan, Poland

Location

60

Sopot, Poland

Location

57

Szczecin, Poland

Location

69

Torun, Poland

Location

53

Warsaw, Poland

Location

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Certolizumab Pegol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: UCB Clinical Trial Call Center
• Organization: UCB

+1 877 822

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2009
• First Posted: February 13, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 30, 2014
• Results First Posted: October 31, 2013

Record last verified: 2014-01

Locations

FR (3); IT (2); PL (9); AU (1); DE (10)