--- title: "Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease" nct_id: NCT00349752 overall_status: TERMINATED phase: PHASE3 sponsor: UCB Pharma study_type: INTERVENTIONAL primary_condition: "Crohn's Disease" countries: United States, Canada, Germany canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00349752.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00349752" ct_last_update_post_date: 2018-08-09 last_seen_at: "2026-05-12T07:29:38.584Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease **Official Title:** A Phase IIIb Multicenter, Double-blind, Placebo-controlled,Randomized Trial to Examine the Corticosteroid-sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease. **NCT ID:** [NCT00349752](https://clinicaltrials.gov/study/NCT00349752) ## Key Facts - **Status:** TERMINATED - **Why Stopped:** Recruitment was stopped early due to slow enrolment of this population. With no safety concerns, the study continued normally for subjects already recruited - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 174 - **Lead Sponsor:** UCB Pharma - **Conditions:** Crohn's Disease - **Start Date:** 2006-11 - **Completion Date:** 2009-07 - **CT.gov Last Update:** 2018-08-09 ## Brief Summary The current study is designed to measure the corticosteroid-sparing effect of certolizumab pegol using a defined schedule of corticosteroid tapering in subjects with moderate to severe Crohn's disease. Subjects had to be in remission (CDAI\<=150) and receiving corticosteroids at a dose no higher than 30 mg/day prednisone or equivalent during the week prior to randomization. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * Men and women * Age 18 years or older with moderate to severe Crohn's disease (Crohn's Disease Activity Index (CDAI) score of ≥ 220 ≤450) Exclusion Criteria: * Active or draining fistula present at screening * Lactating and/or pregnant female subjects * A history of any health condition that could potentially interfere with the disease and/or the treatment * A history of an adverse reaction to polyethylene glycol (PEG) or a protein medicinal product * Any other condition which in the Investigator's judgment would make the patient unsuitable for inclusion in the study * History of drug or alcohol abuse in the prior year * Receipt of any experimental therapy within or outside a clinical trial in the 3 months prior to Visit 0 ``` ## Arms - **Certolizumab pegol 400 mg** (EXPERIMENTAL) — Certolizumab pegol 400 mg - **Placebo** (PLACEBO_COMPARATOR) — Placebo ## Interventions - **certolizumab pegol 400 mg** (BIOLOGICAL) — Certolizumab pegol 400 mg provided in solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36. Two vials will be required for each dosing. - **Placebo** (OTHER) — Placebo (commercially available sodium chloride 0.9% (preservative free)) provided for subcutaneous injection in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36. Two vials will be required for each dosing. ## Primary Outcomes - **Percentage of Subjects Who Have Been Withdrawn From Prednisone or Prednisolone Therapy According to the Corticosteroid Tapering Schedule and Have Remained Off Corticosteroids and in Disease Remission at Week 38** _(time frame: Week 38)_ — The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. ## Secondary Outcomes - **Percentage of Subjects With Continuous Remission Off Steroids at Week 38** _(time frame: Week 38)_ - **Cumulative Percentage of Subjects With Relapse/Treatment Failure at Week 38** _(time frame: Week 38)_ - **Time to Relapse/Treatment Failure During the 38-week Double-blind Treatment Period** _(time frame: During the 38-week double-blind treatment period)_ - **Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period** _(time frame: Over the 38-week double-blind treatment period)_ - **Per-subject Cumulative Dose of Corticosteroids Over the 48-week Study Period** _(time frame: Over the 48-week study period)_ - **Change From the 6-week run-in Period in Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period** _(time frame: 6-week run-in period, 38-week double-blind treatment period)_ - **Crohn's Disease Activity Index (CDAI) Score at Week 38** _(time frame: Week 38)_ - **Change From Baseline in CDAI Score at Week 38** _(time frame: Week 0, Week 38)_ - **Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38** _(time frame: Week 38)_ - **Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38** _(time frame: Week 0, Week 38)_ ## Locations (68) - Birmingham, Alabama, United States - Montgomery, Alabama, United States - Tucson, Arizona, United States - La Jolla, California, United States - Oceanside, California, United States - Orange, California, United States - Palo Alto, California, United States - Roseville, California, United States - Golden, Colorado, United States - Clearwater, Florida, United States - Gainesville, Florida, United States - Hialeah, Florida, United States - Jacksonville, Florida, United States - North Miami Beach, Florida, United States - Sarasota, Florida, United States - Winter Park, Florida, United States - Marietta, Georgia, United States - Savannah, Georgia, United States - Chicago, Illinois, United States - Bloomington, Indiana, United States - Topeka, Kansas, United States - Bowling Green, Kentucky, United States - Louisville, Kentucky, United States - Metairie, Louisiana, United States - Annapolis, Maryland, United States - Newton, Massachusetts, United States - Chesterfield, Michigan, United States - Dearborn, Michigan, United States - Troy, Michigan, United States - Rochester, Minnesota, United States - Ocean Springs, Mississippi, United States - Kansas City, Missouri, United States - Mexico, Missouri, United States - New York, New York, United States - Syracuse, New York, United States - Chapel Hill, North Carolina, United States - Charlotte, North Carolina, United States - Raleigh, North Carolina, United States - Cincinnati, Ohio, United States - Cleveland, Ohio, United States - Dayton, Ohio, United States - Tulsa, Oklahoma, United States - Columbia, South Carolina, United States - Germantown, Tennessee, United States - Austin, Texas, United States - Irving, Texas, United States - Salt Lake City, Utah, United States - Burlington, Vermont, United States - Chesapeake, Virginia, United States - Richmond, Virginia, United States - Seattle, Washington, United States - Madison, Wisconsin, United States - Milwaukee, Wisconsin, United States - Monroe, Wisconsin, United States - Calgary, Alberta, Canada - Edmonton, Alberta, Canada - Abbotsford British Columbia, British Columbia, Canada - Vancouver, British Columbia, Canada - Winnipeg, Manitoba, Canada - Halifax, Nova Scotia, Canada - London, Ontario, Canada - Toronto, Ontario, Canada - Saskatoon, Saskatchewan, Canada - Frankfurt, Germany - Heidleberg, Germany - Jena, Germany - Magdeburg, Germany - Ulm, Germany ## Recent Field Changes (last 30 days) - `design.phases` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.whyStopped` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - 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`locations.|louisville|kentucky|united states` — added _(2026-05-12)_ - `locations.|metairie|louisiana|united states` — added _(2026-05-12)_ - `locations.|annapolis|maryland|united states` — added _(2026-05-12)_ - `locations.|newton|massachusetts|united states` — added _(2026-05-12)_ - `locations.|chesterfield|michigan|united states` — added _(2026-05-12)_ - `locations.|dearborn|michigan|united states` — added _(2026-05-12)_ - `locations.|troy|michigan|united states` — added _(2026-05-12)_ - `locations.|rochester|minnesota|united states` — added _(2026-05-12)_ - `locations.|ocean springs|mississippi|united states` — added _(2026-05-12)_ - `locations.|kansas city|missouri|united states` — added _(2026-05-12)_ - `locations.|mexico|missouri|united states` — added _(2026-05-12)_ - `locations.|new york|new york|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00349752.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00349752* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*