Effects of Infliximab (Remicade) on Fat Free Mass in Patients With Moderate to Severe COPD Suffering From Cachexia

NCT00244192 | Completed Phase 2

• 1 other identifier: EU-073
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether infliximab is effective on fat-free mass in the treatment of patients with moderate to severe COPD suffering from cachexia.

Conditions

COPD; Cachexia

Keywords

COPD; infliximab; Remicade; inflammation; cachexia; fat-free mass; health status; exercise capacity

Outcome Measures

Primary Outcomes (1)

• Fat-free mass

Secondary Outcomes (16)

• Major Secondary Efficacy Endpoints in order of importance:

• a. Change in body weight at 8 weeks

• b. Change from baseline in functional capacity assessed by the incremental shuttle walk test (ISWT) at 8 weeks

• c. Change from baseline in muscle strength (quadriceps, sniff nasal pressure, hand grip strength) at 8 weeks

• d. Change from baseline in St George's Respiratory Disease Questionnaire (SGRQ) at 8 weeks

Interventions

infliximab (Remicade) DRUG

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. COPD acording GOLD with FEV1/FVC ratio \< 70%, and post-bronchodilator FEV1 \> 20% but \< 80% of predicted and an FEV1 of \>500ml.
• \. Fat Free Mass Index : \<17.5 kg/m2 in males, \<15 kg/m2 in females. 3. Symptomatic (eg, chronic cough, sputum production, shortness of breath) for at least 2 months 4. \>= 40 years of age and ≤ 80 years of age 5. History of \>=10 pack years of smoking 6. Men and women of childbearing potential must use adequate birth control measures at least one month prior to screening and for the duration of the study and should continue such precautions for 6 months after receiving the last infusion.
• \. Ability to adhere to the study visit schedule and other protocol requirements 8. Provide signed, written informed consent prior to participation in the study 9. Be adequately immunized against S. pneumoniae. Patients enrolling in the study in autumn and winter months should be immunized against influenza 10. The screening laboratory test results must meet the following criteria:
• Hemoglobin \>= 8.5 g/dL
• WBC \>= 3.5 x 109/L
• Neutrophils \>= 1.5 x 109/L
• Platelets \>= 100 x 109/L
• SGOT (AST) and alkaline phosphatase levels must be within 3 times the upper limit of normal range for the laboratory conducting the test.
• TSH within the normal range of 0.3 to 5 mIU/L. 11. Are considered eligible according to the tuberculosis (TB) eligibility assessment, screening, and early detection of reactivation rules

You may not qualify if:

• \> 11% increase in FEV1 as % of predicted after a fixed dose of bronchodilator (200 µg inhaled salbutamol)
• \>12% variation between screening and baseline FEV1 assessments
• FEV1 \< 500 ml
• Patients with asthma as main component of their obstructive airways disease
• Moderate or severe exacerbation of COPD within previous 2 months
• History or clinical signs of severe cor pulmonale, or pulmonary hypertension, severe right or left sided cardiac failure, serious arrhythmias, myocardial infarction or cardiac interventions within 6 months of screening.
• Exclude patients with right-sided heart defects, as defined by any 1 of the following 3 echocardiography criteria:
• Right ventricular size increased, with an inlet diameter of \>5cm
• Moderate-to-severe tricuspid valve regurgitation
• Exclude patients with the following arrhythmias identified on electrocardiography (ECG):
• Fast atrial fibrillation at ventricular rate of \>90/min
• Atrial-ventricular conduction delay of grade 2 or higher : excludes 2nd and 3rd degree heart block.
• Left bundle branch block, with QRS complex \>120msec.
• Ventricular arrhythmias: ventricular tachycardia and trigeminy.
• \. Chronic respiratory failure (PaO2 \< 7.3kPa with or without hypercapnia) and patients requiring long term oxygen therapy.

Sponsors & Collaborators

• Center for Integrated Rehabilitation and Organ Failure Horn: lead
• Centocor, Inc.: collaborator

Study Sites (1)

Center for Integrated Rehabilitation and Organ failure (CIRO) Horn

Horn, 6085 NM, Netherlands

Location

Related Publications (1)

• van der Vaart H, Koeter GH, Postma DS, Kauffman HF, ten Hacken NH. First study of infliximab treatment in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2005 Aug 15;172(4):465-9. doi: 10.1164/rccm.200501-147OC. Epub 2005 Jun 3.

  PMID: 15937294 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Cachexia; Inflammation

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Thinness

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Emiel FM Wouters, PhD, MD

  University Hospital Maastricht, Department of Respiratory Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 25, 2005
• First Posted: October 26, 2005
• Study Start: October 1, 2003
• Study Completion: December 1, 2005
• Last Updated: December 9, 2005

Record last verified: 2005-10

Locations

NL (1)