SarcoidosisPhase 3NCT00305552
SARCOTHAL. Thalidomide in Skin Sarcoidosis
A Phase 3 study testing THALIDOMIDE in people with Sarcoidosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Sarcoidosis is a multisystem disease involving most frequently the lung, the eyes, the lymph nodes and the skin. Skin lesions may be disfiguring and impair the quality of life. Thalidomide is a multi-target drug that has been shown to be of benefit in skin sarcoidosis in case reports. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis
- What is being tested?
- THALIDOMIDE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2005to Nov 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy proven skin sarcoidosis
- Assessable target skin lesions
Who cannot join
- Rapidly evolving sarcoidosis
- Patients necessitating a corticosteroid regimen of more than 15mg per day.
- Women not willing to undertake a contraceptive method.
- Neurologic impairment
- Past treatment with Thalidomide
- Renal impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Thalidomide vs Placebo in Skin Sarcoidosis
Sarcoidosis is a multisystem disease involving most frequently the lung, the eyes, the lymph nodes and the skin. Skin lesions may be disfiguring and impair the quality of life. Thalidomide is a multi-target drug that has been shown to be of benefit in skin sarcoidosis in case reports. The objective is to assess the efficacy and tolerance of thalidomide in skin sarcoidosis.
Read the detailed description
The study consists in comparing thalidomide to placebo in skin sarcoidosis. Patients with sarcoidosis not necessitating a high-dose corticosteroid regimen, and assessable skin lesions, are eligible. They are randomized and receive either thalidomide or placebo for 3 months. Then they are given Thalidomide for a 3-month open-label period.
- Conditions
- Sarcoidosis
- Being tested
- THALIDOMIDE
- Keywords
- Randomized controlled trial, Thalidomide vs placebo, skin sarcoidosis, Thalidomide
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THALIDOMIDEDrug
THALIDOMIDE
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | THALIDOMIDE Receives: Drug: THALIDOMIDE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of target skin lesions at 3 months.
Size of target skin lesions at 3 months.
Measured: during de study
Secondary outcomes (1)
Physician global assessment at 3 months. Functional assessment of other organs. Side-effects at 3 months.
Physician global assessment at 3 months. Functional assessment of other organs. Side-effects at 3 months.
Measured: during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2006 (estimated)
- Study startFeb 2005
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Michel RYBOJAD, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00305552
- Sponsor's protocol ID
- P031008
- Status last verified
- Jan 2007
- First submitted
- 21 Mar 2006
- Last updated
- 2 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Droitcourt C, Rybojad M, Porcher R, Juillard C, Cosnes A, Joly P, Lacour JP, D'Incan M, Dupin N, Sassolas B, Misery L, Chevrant-Breton J, Lebrun-Vignes B, Desseaux K, Valeyre D, Revuz J, Tazi A, Chosidow O, Dupuy A. A randomized, investigator-masked, double-blind, placebo-controlled trial on thalidomide in severe cutaneous sarcoidosis. Chest. 2014 Oct;146(4):1046-1054. doi: 10.1378/chest.14-0015.
PubMed 24945194
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Thalidomide vs Placebo in Skin Sarcoidosis
- ClinicalTrials.gov ID
- NCT00305552
- Acronym / sponsor ID
- P031008
- Conditions
- Sarcoidosis
- Keywords
- Randomized controlled trial, Thalidomide vs placebo, skin sarcoidosis, Thalidomide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 22 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sarcoidosis is a multisystem disease involving most frequently the lung, the eyes, the lymph nodes and the skin. Skin lesions may be disfiguring and impair the quality of life. Thalidomide is a multi-target drug that has been shown to be of benefit in skin sarcoidosis in case reports. The objective is to assess the efficacy and tolerance of thalidomide in skin sarcoidosis.
Detailed description
The study consists in comparing thalidomide to placebo in skin sarcoidosis. Patients with sarcoidosis not necessitating a high-dose corticosteroid regimen, and assessable skin lesions, are eligible. They are randomized and receive either thalidomide or placebo for 3 months. Then they are given Thalidomide for a 3-month open-label period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: THALIDOMIDETHALIDOMIDE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Biopsy proven skin sarcoidosis
- Assessable target skin lesions
Key exclusion criteria (6 listed)
- Rapidly evolving sarcoidosis
- Patients necessitating a corticosteroid regimen of more than 15mg per day.
- Women not willing to undertake a contraceptive method.
- Neurologic impairment
- Past treatment with Thalidomide
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THALIDOMIDETHALIDOMIDE | Drug | 1 |
Primary outcome
Size of target skin lesions at 3 months.
Time frame: during de study
Size of target skin lesions at 3 months.
1 secondary outcome
Physician global assessment at 3 months. Functional assessment of other organs. Side-effects at 3 months.
Time frame: during the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2011.
- Derived from this study: PubMed 24945194Droitcourt C, Rybojad M, Porcher R, Juillard C, Cosnes A, Joly P, Lacour JP, D'Incan M, Dupin N, Sassolas B, Misery L, Chevrant-Breton J, Lebrun-Vignes B, Desseaux K, Valeyre D, Revuz J, Tazi A, Chosidow O, Dupuy A. A randomized, investigator-masked, double-blind, placebo-controlled trial on thalidomide in severe cutaneous sarcoidosis. Chest. 2014 Oct;146(4):1046-1054. doi: 10.1378/chest.14-0015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel RYBOJAD, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing THALIDOMIDE in people with Sarcoidosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Size of target skin lesions at 3 months. (time frame: during de study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00305552, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2011.