A Placebo Controlled Study to Assess Efficacy and Safety of Certolizumab Pegol in the Treatment of Rheumatoid Arthritis
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ClinicalTrials.gov Identifier: NCT00152386 |
Recruitment Status :
Completed
First Posted : September 9, 2005
Last Update Posted : December 1, 2020
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Condition or disease | Intervention/treatment | Phase |
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Rheumatoid Arthritis | Drug: Certolizumab pegol (CDP870) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 950 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Phase III Multicentre, Double Blind, Placebo-controlled, Parallel Group 52-week Study to Assess the Efficacy and Safety of 2 Dose Regimens of Lyophilised CDP870 as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms and Preventing Structural Damage in Patients With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate |
Study Start Date : | February 2005 |
Actual Primary Completion Date : | October 2006 |
Actual Study Completion Date : | October 2006 |

- To assess the efficacy of CDP870 in combination with Methotrexate in the treatment of Rheumatoid Arthritis and prevention of structural damage by measuring the ACR20 response at week 24 and change from Baseline
- Change from Baseline in mTSS at week 24, Change from Baseline in HAQ-DI at weeks 24 and 52, ACR20 responder rate at week 52, ACR50 and ACR70 responder rate at weeks 24 and 52

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male and female, aged at least 18 years old at the Screening visit.
- A clear chest X-ray within 3 months prior to Baseline visit.
- A diagnosis of adult-onset RA (of at least six months duration but not longer than 15 years prior to Screening) as defined by the 1987 American College of Rheumatology classification criteria.
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Active RA disease at Screening and Baseline as defined by:
- ≥9 tender joints.
- ≥9 swollen joints. and fulfilling 1 of the following 2 criteria:
- ≥30 mm/hour ESR (Westergren), or
- CRP >15 mg/L.
- Must have received a stable dose of MTX with or without folic acid for at least 3 months prior to Baseline visit. The minimum dose is 10 mg MTX weekly.
- Patient must be willing to attend for a Week 52 X-ray of the hands and feet even if they are no longer receiving study treatment but have not withdrawn their informed consent.
Exclusion Criteria:
- A diagnosis of any other inflammatory arthritis e.g., psoriatic arthritis or ankylosing spondylitis.
- A secondary, non-inflammatory type of arthritis (e.g. OA or fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of CDP870 on the patient's primary diagnosis of RA.
- A history of an infected joint prosthesis at any time with prosthesis still in situ.
- Does not meet exclusionary concomitant medication criteria.
- A history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time.
- Patients at a high risk of infection in the Investigator's opinion (e.g. leg ulcers, indwelling urinary catheter and persistent or recurrent chest infections).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00152386

Study Director: | UCB Clinical Trial Call Center | UCB Pharma |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00152386 |
Other Study ID Numbers: |
C87027 2004-002993-49 ( EudraCT Number ) |
First Posted: | September 9, 2005 Key Record Dates |
Last Update Posted: | December 1, 2020 |
Last Verified: | November 2020 |
Rheumatoid Arthritis, CDP870 Certolizumab pegol, Cimzia |
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases |
Immune System Diseases Certolizumab Pegol Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |