NCT00372177

Brief Summary

Rheumatoid arthritis (RA) is a disease with a large economic impact due to the long lasting disabling nature of the disease. Furthermore, diagnosis of the disease is difficult and only a scheme with different symptoms is used to diagnose rheumatoid arthritis, often only by probability. Due to the fact that effective disease modifying pharmacological treatment is available and should be started early in established cases of RA, in combination with the adverse effect potential of these substances (e.g. methotrexate), a fast reliable diagnostic tool to diagnose rheumatoid arthritis would be highly appreciated by the medical community and the patients. Furthermore, for invasive treatments (surgery, puncture), an imaging method to display the activity pattern in different joints would be a major advantage. For the evaluation of the effectiveness of pharmacological therapy in rheumatoid arthritis, up to now, radiological measurements of the destruction process of the joints are used. This method has the disadvantage that it is time consuming insofar as changes in the radiological images must occur. It allows only an evaluation if the joints are destructed (which should be excluded by the new therapy regimen). Again, a quantifiable method for the determination of the effects of new therapeutic approaches would be highly appreciated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 6, 2006

Completed
10 months until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

May 28, 2008

Status Verified

May 1, 2008

Enrollment Period

10 months

First QC Date

September 5, 2006

Last Update Submit

May 26, 2008

Conditions

Rheumatoid ArthritisPolyarthritisRheumatismAutoimmune DiseaseInflammation

Keywords

monoclonal antibodydiagnosticsRAImmunoglobulinsmolecular targetTc99m-pertechnetateFab-fragment of Anti-human CD4Radiopharmaceuticalchronic inflammatory diseasesactive Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • safety and tolerability of this diagnostic agent

    duration of study

Secondary Outcomes (1)

  • endpoint for the proof of concept will be the number of patients needed to obtain a series of equal results

    duration of study

Study Arms (1)

EP1645

ACTIVE COMPARATOR

Single-Dose

Radiation: Fab-fragment of Anti-human CD4

Interventions

Fab-fragment of Anti-human CD4RADIATION

Sterile lyophilized Powder for Preparation of a Solution and sterile labelling Buffer labelling with Tc99m-Pertechnetat Intravenous injection

EP1645

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female subjects above 50 years of age
  • Suffering from joint pain which is due to active rheumatoid arthritis
  • Obvious signs of inflammation in at least one joint (e.g. swelling, erythema, or local elevated temperature)
  • Otherwise healthy
  • Informed consent

You may not qualify if:

  • Patients 80 years and older
  • Clinically significant disease of the cardiovascular system, respiratory system, hepato-biliary system or central nervous system (CNS)
  • Excretory hepatic or renal insufficiency
  • Regular intake of any drug, except for hormone replacement therapy in females
  • Previous administration of xenogenous proteins
  • History of anaphylactic reaction to any drug administered by a parenteral pathway
  • Previous participation in a radiopharmaceutical drug trial (unless the effective dose acquired by participation in the current trial will remain below 10 mSv)
  • Participation in any clinical drug trial within 3 months prior to enrolment
  • Women of child-bearing potential (child-bearing potential to be ruled out by one of the following: at least 2 years past menopause, hysterectomy, bilateral oophorectomy, or bilateral tubal ligation)
  • Long term medication with strong antiphlogistic agents/pain killers such as methotrexate, corticoids, or immunosuppressants prior to enrolment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic and Policlinic for Nuclear Medicine, Medical faculty, University of Leipzig

Leipzig, Saxony, 04103, Germany

Location

Related Links

MeSH Terms

Conditions

Arthritis, RheumatoidArthritisRheumatic DiseasesAutoimmune DiseasesInflammation

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Osama Sabri, Prof. Dr.

    Clinic and Policlinic for Nuclear Medicine, Medical Faculty, University of Leipzig, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 5, 2006

First Posted

September 6, 2006

Study Start

July 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

May 28, 2008

Record last verified: 2008-05

Locations

DE(1)