Effect of Anti TNFa Upon Deep Endometriosis Associated Pain (Infliximab)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00604864
Recruitment Status : Completed
First Posted : January 30, 2008
Last Update Posted : January 30, 2008
Information provided by:
Katholieke Universiteit Leuven

Brief Summary:
Deep endometriosis associated pain is believed to be caused by inflammation. Anti TNFa has been proved to be an effective treatment for other inflammation related conditions as Crohn's disease Endometriosis is associated with an inflammatory response in the pelvis, which is mediated by a number of cytokines including TNF-α. It has therefore been suggested that infliximab, an anti-TNF-α monoclonal antibody, might relieve pain in affected women.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: anti TNFa monoclonal antibody - Infliximab Drug: placebo Phase 2

Detailed Description:

In this pilot study, 21 women with severe endometriosis-associated pain and a rectovaginal nodule, at least 1 cm in diameter on clinical examination, were randomised in a 2 to 1 ratio to receive intravenous infliximab (n=14) or placebo (n=7) in the three months prior to laparoscopic laser excision of the nodule.

After a 1 month observation period, all women received three infusions of infliximab (5mg/kg) or placebo over the course of 6 weeks. Surgery was performed 3 months later and follow-up continued for a further 6 months. The primary endpoint was the total pain burden (dysmenorrhoea, deep dyspareunia and non-menstrual pain) rated on a daily basis by the patient using standard pain scales and analgesic intake as the outcome measures . Secondary endpoints included the volume of the endometriotic nodule assessed clinically and on transvaginal ultrasound, the amount of pelvic tenderness on clinical examination and the presence of other endometriotic lesions at laparoscopy.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Anti TNFa Treatment for Deep Endometriosis Associated Pain : a Randomised Placebo Controlled Trial.
Study Start Date : February 2004
Actual Primary Completion Date : February 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis
Drug Information available for: Infliximab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
women with a deep endometriosis nodule of at least 1 cm in diameter; and severe pain (at least one severe pain score on Biberoglu Behrman scale)
Drug: anti TNFa monoclonal antibody - Infliximab
Chimeric A2 (infliximab, RemicadeTM) IgG ; 100 mg infliximab IgG, Infliximab was freshly prepared immediately before each administration. Infliximab or placebo was administered as a slow infusion of 250mL on weeks 0, 2 and 6. Women were closely observed during, and for 1 hour after, the infusion in the event of any serious adverse reactions.
Placebo Comparator: 2
women with a deep endometriosis nodule of at least 1 cm in diameter; and severe pain (at least one severe pain score on Biberoglu Behrman scale)
Drug: placebo

Primary Outcome Measures :
  1. Endometriosis associated pain [ Time Frame: By the clinician after 1, 2 and 3 months ; by the patient daily for 3 months ]

Secondary Outcome Measures :
  1. decrease in volume of deep endometriosis nodule [ Time Frame: after 1, 2 and 3 months of treatment ]

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • The patients (aged 18-50 years) were all recruited from a single, tertiary referral hospital at Leuven University, Belgium, specialising in the surgical treatment of severe endometriosis.
  • All the women were symptomatic and scheduled for surgical excision of a rectovaginal nodule, at least 1 cm in diameter, diagnosed on the basis of clinical examination at the time of menstruation.
  • All the women had a menstrual cycle occurring every 25 to 40 days.
  • If previously treated with hormonal medication for endometriosis, at least 3 months must have elapsed and they must have had at least two menstrual cycles since stopping treatment.
  • Unless the women had previously been sterilised, they had to agree to use a double-barrier method of contraception for the duration of the study and for up to 6 months after receiving the last infusion.
  • The study was approved by the Institutional Review Board of Leuven University.
  • Written, informed consent was obtained before any study related procedures were performed.

Exclusion Criteria:

  • Evidence on chest x-ray in the previous 3 months of old or currently active TB, or other history/evidence of active TB, even if adequately treated
  • Evidence of serious infections (such as pneumonia or pyelonephritis) in the previous 3 months
  • Evidence of a documented HIV infection, active hepatitis-B or C, or an opportunistic infection (e.g. herpes zoster, cytomegalovirus, pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) in the previous 6 months
  • Previous transplant surgery, a lymphoproliferative disorder or other malignancy
  • Positive cervical cytology in the previous 6 months
  • Previous treatment with infliximab, any drug known to affect TNF-α levels, e.g. pentoxifylline, thalidomide and etanercept, or any human/murine recombinant products
  • Known allergy to murine products
  • Use of other investigational drugs within 1 month of recruitment or within 5 half-lives of the investigational agent, whichever was longer
  • Any haematological or biochemical abnormalities on routine screening.
  • Subjects were also excluded if there was any pelvic pathology on transvaginal ultrasound scan (TVS) other than small uterine fibroids (< 4 cm in diameter) and an ovarian endometrioma or endometriotic nodule.

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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 identifier (NCT number): NCT00604864

University Hospital Gasthuisberg
Leuven, Belgium, 3000
Sponsors and Collaborators
Katholieke Universiteit Leuven
Principal Investigator: Philippe R Koninckx, MD, PhD Catholic University Leuven

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Koninckx Philippe, UZ Gasthuisberg, Catholic University Leuven Identifier: NCT00604864     History of Changes
Other Study ID Numbers: trial_EU-0053/endometriosis
First Posted: January 30, 2008    Key Record Dates
Last Update Posted: January 30, 2008
Last Verified: January 2008

Keywords provided by Katholieke Universiteit Leuven:
deep endometriosis
pelvic pain
anti TNFa

Additional relevant MeSH terms:
Genital Diseases, Female
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents