Study of Therapeutic Options for Subjects Discontinuing Efalizumab and Experiencing Disease Recurrence
Sponsor
Merck KGaA, Darmstadt, Germany (Industry)
Overall Status
Completed
CT.gov ID
NCT01079988
Collaborator
(none)
41
5
14
Study Details
Study Description
Brief Summary
This is a pilot investigational study of the appropriate therapeutic regimens to treat subjects experiencing inflammatory recurrence (rebound) of psoriatic disease upon discontinuation of efalizumab therapy and of the biological mechanisms involved in inflammatory disease recurrence and control.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
41 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase IV Open Label, Multicentre, Investigational Study of the Therapeutic Options for Subjects Discontinuing Efalizumab Therapy and Experiencing Inflammatory Disease Recurrence
Study Start Date
:
Feb 1, 2004
Actual Primary Completion Date
:
Dec 1, 2004
Actual Study Completion Date
:
Apr 1, 2005
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cyclosporin Starting dose 4.0 - 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks. |
Drug: Cyclosporins
Starting dose 4.0 - 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks.
|
| Experimental: Retinoids Starting dose 25 - 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped. |
Drug: Retinoids
Starting dose 25 - 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped.
|
| Experimental: Systemic corticosteroids Starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks. |
Drug: Systemic corticosteroids
Starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks.
|
| Experimental: Methotrexate Starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks. |
Drug: Methotrexate
Starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks.
|
| Experimental: Systemic corticosteroids/methotrexate Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks. |
Drug: Systemic corticosteroids/methotrexate
Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks.
|
Outcome Measures
Primary Outcome Measures
- Physician's Global Assessment (PGA) of Change Over Time (Good or Better) [12 weeks]
The PGA response was classified according to the following categories by changes in all clinical signs and symptoms as compared to baseline: Cleared: Remission except for residual manifestations such as mild erythema (100% improvement) Excellent: Improvement of 75%-99% except for residual manifestations such as mild erythema Good: Improvement of 50%-74%
Secondary Outcome Measures
- Patient's Global Psoriasis Assessment (PGPA) [12 weeks]
The PGPA consisted of a single self-explanatory item: On a scale from 0 to 10, with 0 being no psoriasis and 10 the worst psoriasis that you can imagine, please rate the state of your psoriasis right now. Note: Consider only your skin condition and do not consider other aspects that may be related to your psoriasis (such as psoriatic arthritis).
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Participation in Genentech study ACD2601g, Genentech study HUPA 600 or Serono study IMP24011.
-
Inflammatory psoriasis disease recurrence occurring up to 2 months after discontinuation of efalizumab that required immediate therapeutic control in the opinion of the Investigator. Psoriasis had to be rapidly developing, symptomatic and inflammatory in nature.
-
Written informed consent, given prior to any study-related procedure not part of the subject's normal medical care, with the understanding that the subject could withdraw consent at any time without prejudice to his or her future medical care.
-
Female subjects had to be neither pregnant nor breast-feeding, and had to lack childbearing potential, as defined by either:
-
Being post-menopausal or surgically sterile, or
-
Using an accepted form of contraception.
-
Confirmation that the subject was not pregnant had to be established by a negative urinary hCG test at SD1. A pregnancy test was not required if the subject was post-menopausal or surgically sterile.
-
Outpatient status at the time of enrolment.
Exclusion Criteria:
- Disease recurrence that was part of the natural disease progression, was not inflammatory in nature, and was not related to efalizumab study medication in the previous study.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Merck KGaA, Darmstadt, Germany
Investigators
- Study Director: Patrick Natta, MD, Merck Serono SA
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier:
NCT01079988
Other Study ID Numbers:
- 25180
First Posted:
Mar 3, 2010
Last Update Posted:
Feb 27, 2014
Last Verified:
Jan 1, 2014
Keywords provided by Merck KGaA, Darmstadt, Germany
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Study Initiation Date: 24 February 2004 (first patient, first visit) Study Completion Date: 21 December 2004 (last patient, last visit) Study Centres: 9 clinical centres in Canada |
|---|---|
| Pre-assignment Detail | Subjects who satisfied the study's entry criteria were assigned to receive one of five treatment regimens involving accepted therapies for moderate to severe psoriasis |
| Arm/Group Title | Cyclosporin | Retinoids | Systemic Corticosteroids | Methotrexate | Systemic Corticosteroids/Methotrexate |
|---|---|---|---|---|---|
| Arm/Group Description | Starting dose 4.0 - 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks. | Starting dose 25 - 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped. | Starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks. | Starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks. | Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks. |
| Period Title: Overall Study | |||||
| STARTED | 10 | 1 | 8 | 20 | 2 |
| COMPLETED | 9 | 1 | 8 | 17 | 1 |
| NOT COMPLETED | 1 | 0 | 0 | 3 | 1 |
Baseline Characteristics
| Arm/Group Title | Cyclosporin | Retinoids | Systemic Corticosteroids | Methotrexate | Systemic Corticosteroids/Methotrexate | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Starting dose 4.0 - 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks. | Starting dose 25 - 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped. | Starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks. | Starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks. | Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks. | Total of all reporting groups |
| Overall Participants | 10 | 1 | 8 | 20 | 2 | 41 |
| Age (years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [years] |
43
(12)
|
41
|
44
(11)
|
49
(10)
|
47
(3)
|
46
(11)
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
5
50%
|
0
0%
|
3
37.5%
|
7
35%
|
1
50%
|
16
39%
|
| Male |
5
50%
|
1
100%
|
5
62.5%
|
13
65%
|
1
50%
|
25
61%
|
| Region of Enrollment (participants) [Number] | ||||||
| Canada |
10
100%
|
1
100%
|
8
100%
|
20
100%
|
2
100%
|
41
100%
|
Outcome Measures
| Title | Physician's Global Assessment (PGA) of Change Over Time (Good or Better) |
|---|---|
| Description | The PGA response was classified according to the following categories by changes in all clinical signs and symptoms as compared to baseline: Cleared: Remission except for residual manifestations such as mild erythema (100% improvement) Excellent: Improvement of 75%-99% except for residual manifestations such as mild erythema Good: Improvement of 50%-74% |
| Time Frame | 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Cyclosporin | Retinoids | Systemic Corticosteroids | Methotrexate | Systemic Corticosteroids/Methotrexate |
|---|---|---|---|---|---|
| Arm/Group Description | Starting dose 4.0 - 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks. | Starting dose 25 - 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped. | Starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks. | Starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks. | Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks. |
| Measure Participants | 10 | 1 | 8 | 20 | 2 |
| Number [participants] |
7
70%
|
0
0%
|
2
25%
|
9
45%
|
0
0%
|
| Title | Patient's Global Psoriasis Assessment (PGPA) |
|---|---|
| Description | The PGPA consisted of a single self-explanatory item: On a scale from 0 to 10, with 0 being no psoriasis and 10 the worst psoriasis that you can imagine, please rate the state of your psoriasis right now. Note: Consider only your skin condition and do not consider other aspects that may be related to your psoriasis (such as psoriatic arthritis). |
| Time Frame | 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| One patient withdrew |
| Arm/Group Title | Cyclosporin | Retinoids | Systemic Corticosteroids | Methotrexate | Systemic Corticosteroids/Methotrexate |
|---|---|---|---|---|---|
| Arm/Group Description | Starting dose 4.0 - 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks. | Starting dose 25 - 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped. | Starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks. | Starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks. | Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks. |
| Measure Participants | 10 | 1 | 8 | 19 | 2 |
| Mean (Standard Deviation) [PGPA score] |
5.1
(2.4)
|
4.0
|
5.5
(2.8)
|
4.8
(2.7)
|
4.5
(0.7)
|
Adverse Events
| Time Frame | Adverse events were monitored throughout the study | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Information about adverse events was obtained at study visits following physical examination, through spontaneous reports by the subjects and through questioning of the subjects. Adverse event data could also be obtained from subject diary cards, but such information had to be reviewed and assessed medically before it was transcribed to the CRF. | |||||||||
| Arm/Group Title | Cyclosporin | Retinoids | Systemic Corticosteroids | Methotrexate | Systemic Corticosteroids/Methotrexate | |||||
| Arm/Group Description | Starting dose 4.0 - 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks. | Starting dose 25 - 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped. | Starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks. | Starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks. | Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks. | |||||
All Cause Mortality |
||||||||||
| Cyclosporin | Retinoids | Systemic Corticosteroids | Methotrexate | Systemic Corticosteroids/Methotrexate | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
| Cyclosporin | Retinoids | Systemic Corticosteroids | Methotrexate | Systemic Corticosteroids/Methotrexate | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | 0/1 (0%) | 0/8 (0%) | 0/20 (0%) | 0/2 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| Cyclosporin | Retinoids | Systemic Corticosteroids | Methotrexate | Systemic Corticosteroids/Methotrexate | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/10 (90%) | 0/1 (0%) | 4/8 (50%) | 11/20 (55%) | 0/2 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| Gastritis | 0/10 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/20 (5%) | 0/2 (0%) | |||||
| Nausea | 1/10 (10%) | 0/1 (0%) | 0/8 (0%) | 1/20 (5%) | 0/2 (0%) | |||||
| Abdominal pain | 1/10 (10%) | 0/1 (0%) | 0/8 (0%) | 0/20 (0%) | 0/2 (0%) | |||||
| Anal fissure | 0/10 (0%) | 0/1 (0%) | 1/8 (12.5%) | 0/20 (0%) | 0/2 (0%) | |||||
| Gastrooesophageal reflux disease | 0/10 (0%) | 0/1 (0%) | 0/8 (0%) | 1/20 (5%) | 0/2 (0%) | |||||
| Glossodynia | 1/10 (10%) | 0/1 (0%) | 0/8 (0%) | 0/20 (0%) | 0/2 (0%) | |||||
| Haemorrhoidal haemorrhage | 0/10 (0%) | 0/1 (0%) | 0/8 (0%) | 1/20 (5%) | 0/2 (0%) | |||||
| Tongue disorder | 1/10 (10%) | 0/1 (0%) | 0/8 (0%) | 0/20 (0%) | 0/2 (0%) | |||||
| General disorders | ||||||||||
| Fatigue | 0/10 (0%) | 0/1 (0%) | 1/8 (12.5%) | 0/20 (0%) | 0/2 (0%) | |||||
| Rigors | 0/10 (0%) | 0/1 (0%) | 1/8 (12.5%) | 0/20 (0%) | 0/2 (0%) | |||||
| Infections and infestations | ||||||||||
| Influenza | 1/10 (10%) | 0/1 (0%) | 0/8 (0%) | 2/20 (10%) | 0/2 (0%) | |||||
| Nasopharyngitis | 2/10 (20%) | 0/1 (0%) | 0/8 (0%) | 0/20 (0%) | 0/2 (0%) | |||||
| Upper respiratory tract infection | 0/10 (0%) | 0/1 (0%) | 0/8 (0%) | 2/20 (10%) | 0/2 (0%) | |||||
| Urinary tract infection | 2/10 (20%) | 0/1 (0%) | 0/8 (0%) | 0/20 (0%) | 0/2 (0%) | |||||
| Furuncle | 0/10 (0%) | 0/1 (0%) | 0/8 (0%) | 1/20 (5%) | 0/2 (0%) | |||||
| Herpes zoster ophthalmic | 1/10 (10%) | 0/1 (0%) | 0/8 (0%) | 0/20 (0%) | 0/2 (0%) | |||||
| Pneumonia | 0/10 (0%) | 0/1 (0%) | 0/8 (0%) | 1/20 (5%) | 0/2 (0%) | |||||
| Rhinitis | 1/10 (10%) | 0/1 (0%) | 0/8 (0%) | 0/20 (0%) | 0/2 (0%) | |||||
| Sinusitis | 0/10 (0%) | 0/1 (0%) | 0/8 (0%) | 1/20 (5%) | 0/2 (0%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Muscle strain | 1/10 (10%) | 0/1 (0%) | 0/8 (0%) | 0/20 (0%) | 0/2 (0%) | |||||
| Investigations | ||||||||||
| Alanine aminotransferase increased | 0/10 (0%) | 0/1 (0%) | 0/8 (0%) | 1/20 (5%) | 0/2 (0%) | |||||
| Blood glucose increased | 0/10 (0%) | 0/1 (0%) | 1/8 (12.5%) | 0/20 (0%) | 0/2 (0%) | |||||
| Blood pressure increased | 1/10 (10%) | 0/1 (0%) | 0/8 (0%) | 0/20 (0%) | 0/2 (0%) | |||||
| Blood urea increased | 1/10 (10%) | 0/1 (0%) | 0/8 (0%) | 0/20 (0%) | 0/2 (0%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Hypercholesterolaemia | 0/10 (0%) | 0/1 (0%) | 0/8 (0%) | 1/20 (5%) | 0/2 (0%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Myalgia | 1/10 (10%) | 0/1 (0%) | 0/8 (0%) | 1/20 (5%) | 0/2 (0%) | |||||
| Arthralgia | 1/10 (10%) | 0/1 (0%) | 0/8 (0%) | 0/20 (0%) | 0/2 (0%) | |||||
| Back pain | 1/10 (10%) | 0/1 (0%) | 0/8 (0%) | 0/20 (0%) | 0/2 (0%) | |||||
| Muscle cramp | 1/10 (10%) | 0/1 (0%) | 0/8 (0%) | 0/20 (0%) | 0/2 (0%) | |||||
| Pain in extremity | 1/10 (10%) | 0/1 (0%) | 0/8 (0%) | 0/20 (0%) | 0/2 (0%) | |||||
| Rheumatoid arthritis | 0/10 (0%) | 0/1 (0%) | 0/8 (0%) | 1/20 (5%) | 0/2 (0%) | |||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Skin papilloma | 1/10 (10%) | 0/1 (0%) | 0/8 (0%) | 0/20 (0%) | 0/2 (0%) | |||||
| Nervous system disorders | ||||||||||
| Headache | 1/10 (10%) | 0/1 (0%) | 2/8 (25%) | 1/20 (5%) | 0/2 (0%) | |||||
| Paraesthesia | 1/10 (10%) | 0/1 (0%) | 1/8 (12.5%) | 0/20 (0%) | 0/2 (0%) | |||||
| Psychiatric disorders | ||||||||||
| Restlessness | 0/10 (0%) | 0/1 (0%) | 1/8 (12.5%) | 0/20 (0%) | 0/2 (0%) | |||||
| Reproductive system and breast disorders | ||||||||||
| Postmenopausal haemorrhage | 0/10 (0%) | 0/1 (0%) | 0/8 (0%) | 1/20 (5%) | 0/2 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Chronic obstructive airways disease | 1/10 (10%) | 0/1 (0%) | 0/8 (0%) | 0/20 (0%) | 0/2 (0%) | |||||
| Cough | 0/10 (0%) | 0/1 (0%) | 0/8 (0%) | 1/20 (5%) | 0/2 (0%) | |||||
| Vascular disorders | ||||||||||
| Hypertension | 1/10 (10%) | 0/1 (0%) | 0/8 (0%) | 0/20 (0%) | 0/2 (0%) | |||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Merck KGaA Communication Center |
|---|---|
| Organization | Merck Serono, a division of Merck KGaA, Darmstadt, Germany |
| Phone | +49-6151-72-5200 |
| service@merckgroup.com |
Responsible Party:
Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier:
NCT01079988
Other Study ID Numbers:
- 25180
First Posted:
Mar 3, 2010
Last Update Posted:
Feb 27, 2014
Last Verified:
Jan 1, 2014