Trial · NCT02108210
Cytokine Inhibition in Chronic Fatigue Syndrome Patients
NCT02108210, Phase 2, Phase 3, Completed, Radboud University Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cytokine Inhibition in Chronic Fatigue Syndrome Patients. Trials, record NCT02108210. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02108210
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cytokine Inhibition in Chronic Fatigue Syndrome Patients
- NCT number
- NCT02108210
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 50 participants, actual
- Lead sponsor
- Radboud University Medical Center
- Conditions
- Chronic Fatigue Syndrome
- Interventions
- Anakinra, Placebo
- First posted
- 2014-04-09
- Last updated
- 2016-05-25
- Other registries' IDs
- eudract:2013-005466-19
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | CIS (checklist individual strength, compared to baseline) | 4 weeks, measurement will be repeated up to 26 weeks | To investigate the role of the cytokine IL-1 in the pathogenesis of CFS and to find leads for future treatment of CFS, a disorder for which there is no proven effective drug treatment. The primary outcome measure will be fatigue severity at 4 weeks measured with the Checklist Individual Strength (CIS). |
| Secondary | SIP8 (sickness impact profile, change from baseline) | 4 weeks, measurement will be repeated up to 26 weeks | level of functional impairment |
| Secondary | SF-36 (subscale physical functioning and social functioning, compared to baseline) | 4 weeks, measurement will be repeated up to 26 weeks | physical and social functioning assessed with the subscale physical functioning and social functioning of the SF-36 |
| Secondary | SCL-90 (symptom checklist-90, compared to baseline) | 4 weeks, measurement will be repeated up to 26 weeks | level of psychological distress assessed with the total score on the Symptom Checklist-90 |
| Secondary | VAS pain (visual analog scale, compared to baseline) | 4 weeks, measurement will be repeated up to 26 weeks | pain severity assessed with a Visual Analog Scale |
| Secondary | Cortisol in saliva and hair (concentration compared to baseline) | 4 weeks | Because of the possible role of the hypothalamus-pituitary-adrenal axis we will also measure the cortisol concentration in saliva and hair. For the baseline assessment, comparison will be made with matched neighbourhood controls. |
| Secondary | microbiome determination faeces | at baseline | A new field of great interest in pathophysiology is the role of the microbial flora of the host (microbiome). The availability of well defined patients with CFS and matched controls is a great opportunity in an unexplored area of CFS research, to assess whether the microbiome of CFS patients is peculiar. |
| Secondary | cytokine concentrations in blood and saliva (compared to baseline) | 4 weeks | In addition to the cytokine intervention, we will assess cytokines (at the transcriptional level and as proteins) in serum and saliva at baseline and after 4 weeks of intervention. For the baseline assessment, comparison will be made with matched neighbourhood controls. |
| Other | Body temperature | 4 weeks, measurement will be repeated up to 26 weeks | |
| Other | pulse rate | 4 weeks, measurement will be repeated up to 26 weeks |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02108210
GET https://conductscience.org/api/trials/v1/NCT02108210/registered