A Phase 3 interventional study of Certolizumab pegol (CDP870) in Crohn's Disease, sponsored by UCB Pharma. Completed at 65 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-07.
Sponsored by UCB Pharma · Phase 3, Interventional, and Treatment
The study will continue to assess the safety of certolizumab pegol (CDP870) as well as examine the evolution of long term efficacy in Crohn's disease patients who completed study C87042 [NCT00308581]. It will also assess the effect of subcutaneous CDP870 400 mg on direct cost parameters.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 233 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →UCB Pharma is the lead sponsor of 238 studies on the registry; none are open to participants now.
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Exclusion Criteria:
400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Biological: Certolizumab pegol (CDP870)
400 mg subcutaneous (sc) injection of Certolizumab pegol (CDP870) every 2 (Q2W) or 4 (Q4W) weeks
Also known as: CDP870, Cimzia
Occurrence of at Least One Study-emergent Adverse Event During the Study (Maximum 164 Weeks)
Study-emergent adverse events are defined as treatment-emergent adverse events with an onset date on or after the first study drug administration date of this study but not later than 12 weeks (84 days) after last injection. Results are presented as the percentage of subjects with at least one treatment-emergent adverse event during this study.
Time frame: Maximum 164 weeks
Maintenance of Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] Among the Subjects in Clinical Response at Baseline of This Study (Week 26 of Study C87042).
Clinical response is defined as at least a 100 point decrease from Baseline of study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI). Subjects maintained their clinical response at Last Visit if they did not meet criteria for loss of response \[CDAI score \>150 points and a minimum increase in CDAI of 70 points versus Baseline of study C87042 (NCT00308581)\] at 2 consecutive visits. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects maintaining response at Last visit.
Time frame: Baseline (corresponding to Week 26 of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Clinical Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Clinical response is defined as at least a 100 point decrease from Baseline of study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects achieving clinical response at Last visit.
Time frame: Baseline of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Remission at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects in remission at Last visit.
Time frame: Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Change From Baseline of Study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI) at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Time frame: Baseline of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Time to Loss of Response After Baseline of Study C87042 (NCT00308581) on Subjects Who Were in Clinical Response at Baseline of This Study
Clinical response at Baseline of this study of at least a 100 point decrease from Baseline of study C87042 in Crohn's Disease Activity Index (CDAI) Loss of response = both a CDAI score \>150 points and a minimum increase in CDAI of 70 points versus Baseline (Week 26 of study C87042) as confirmed at 2 consecutive visits. Subjects losing response will be considered as having the event on the date of the first visit where response was lost. Subjects who discontinued the study without having lost response will be censored on the date of discontinuation (i.e. date of last visit performed).
Time frame: Maximum 154 weeks
Occurrence of at Least 1 Hospital Stay During the Treatment Period
The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Results are presented as the percentage of subjects with at least 1 hospital stay during the treatment period.
Time frame: Maximum 152 weeks
Occurrence of at Least 1 Hospital Stay During the Follow-Up Period
Follow-up period starts the day after the last injection up to 84 days after last injection. Results are presented as the percentage of subjects with at least 1 hospital stay during the follow-up period.
Time frame: Maximum 12 weeks
Occurrence of at Least 1 Hospital Stay During the During the Overall Period
Overall period corresponds to both treatment and follow-up periods in C87046. Results are presented as the percentage of subjects with at least 1 hospital stay during the overall period.
Time frame: Maximum 164 weeks
Length of Hospital Stays During the Treatment Period
The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.
Time frame: Maximum 152 weeks
Length of Hospital Stays During the Follow-Up Period
Follow-up period starts the day after the last injection up to 84 days after last injection.
Time frame: Maximum 12 weeks
Length of Hospital Stays During the Overall Period
Overall period corresponds to both treatment and follow-up periods in C87046.
Time frame: Maximum 164 weeks
Occurrence of at Least 1 Emergency Room Visit During the Treatment Period
The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Results are presented as the percentage of subjects with at least 1 emergency room visit during the treatment period.
Time frame: Maximum 152 weeks
Occurrence of at Least 1 Emergency Room Visit During the Follow-Up Period
Follow-up period starts the day after the last injection up to 84 days after last injection. Results are presented as the percentage of subjects with at least 1 emergency room visit during the follow-up period.
Time frame: Maximum 12 weeks
Occurrence of at Least 1 Emergency Room Visit During the Overall Period
Overall period corresponds to both treatment and follow-up periods in C87046. Results are presented as the percentage of subjects with at least 1 emergency room visit during the overall period.
Time frame: Maximum 164 weeks
Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Treatment Period
The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics. Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the treatment period.
Time frame: Maximum 152 weeks
Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Follow-Up Period
Follow-up period start the day after the last injection up to 84 days after last injection. Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics. Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the follow-up period.
Time frame: Maximum 12 weeks
Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Overall Period
Overall period corresponds to both treatment and follow-up periods in C87046. Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics. Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the overall period.
Time frame: Maximum 164 weeks
Occurrence of at Least 1 General Concomitant Medication During the Treatment Period
The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Results are presented as the number of subjects who used at least 1 concomitant medication during the treatment period.
Time frame: Maximum 152 weeks
Occurrence of at Least 1 General Concomitant Medication During the Follow-Up Period
Follow-up period start the day after the last injection up to 84 days after last injection. Results are presented as the number of subjects who used at least 1 concomitant medication during the follow-up period.
Time frame: Maximum 12 weeks
Occurrence of at Least 1 General Concomitant Medication During the Overall Period
Overall period corresponds to both treatment and follow-up periods in C87046. Results are presented as the number of subjects who used at least 1 concomitant medication during the overall period.
Time frame: Maximum 164 weeks
Occurrence of at Least 1 Concurrent Medical Procedure During the Treatment Period.
The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the treatment period.
Time frame: Maximum 152 weeks
Occurrence of at Least 1 Concurrent Medical Procedure During the Follow-Up Period
Follow-up period start the day after the last injection up to 84 days after last injection. Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the follow-up period.
Time frame: Maximum 12 weeks
Occurrence of at Least 1 Concurrent Medical Procedure During the Overall Period
Overall period corresponds to both treatment and follow-up periods in C87046. Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the overall period.
Time frame: Maximum 164 weeks
This study started in October 2006, with recruitment in the United States, Austria, Belgium, Canada, France, Germany, Italy, Spain, Sweden, Switzerland, the United Kingdom and the Netherlands. This study completed in April 2010.
| Milestone | Certolizumab Pegol 400 mg |
|---|---|
| Started | 233 |
| Completed | 71 |
| Not completed | 162 |
| Withdrew: Adverse event | 44 |
| Withdrew: Lack of efficacy | 80 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Withdrawal by subject | 24 |
| Withdrew: Other: non-compliance | 2 |
| Withdrew: Other: moved | 2 |
| Withdrew: Other: recurrent squamaous cell cancer | 1 |
| Withdrew: Other: investigator decision | 1 |
| Withdrew: Other: quality of life concern | 1 |
| Withdrew: Other: sponsor decision | 1 |
| Withdrew: Other: subject in need of an entocort | 1 |
| Withdrew: Other: medical monitor decision | 1 |
| Withdrew: Other: physician decision | 1 |
| Withdrew: Other: signed consent for another study | 1 |
Study-emergent adverse events are defined as treatment-emergent adverse events with an onset date on or after the first study drug administration date of this study but not later than 12 weeks (84 days) after last injection. Results are presented as the percentage of subjects with at least one treatment-emergent adverse event during this study.
| percentage of participants | Certolizumab Pegol 400 mg |
|---|---|
| Occurrence of at Least One Study-emergent Adverse Event During the Study (Maximum 164 Weeks) | 92.6 |
Clinical response is defined as at least a 100 point decrease from Baseline of study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI). Subjects maintained their clinical response at Last Visit if they did not meet criteria for loss of response \[CDAI score \>150 points and a minimum increase in CDAI of 70 points versus Baseline of study C87042 (NCT00308581)\] at 2 consecutive visits. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects maintaining response at Last visit.
| percentage of participants | Certolizumab Pegol 400 mg |
|---|---|
| Maintenance of Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] Among the Subjects in Clinical Response at Baseline of This Study (Week 26 of Study C87042). | 61.8 |
Clinical response is defined as at least a 100 point decrease from Baseline of study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects achieving clinical response at Last visit.
| percentage of participants | Certolizumab Pegol 400 mg |
|---|---|
| Clinical Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] | 53.3 |
Remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects in remission at Last visit.
| percentage of participants | Certolizumab Pegol 400 mg |
|---|---|
| Remission at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] | 40.6 |
CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
| score on a scale | Certolizumab Pegol 400 mg |
|---|---|
| Change From Baseline of Study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI) at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] | -121.52 ± 99.61 |
Clinical response at Baseline of this study of at least a 100 point decrease from Baseline of study C87042 in Crohn's Disease Activity Index (CDAI) Loss of response = both a CDAI score \>150 points and a minimum increase in CDAI of 70 points versus Baseline (Week 26 of study C87042) as confirmed at 2 consecutive visits. Subjects losing response will be considered as having the event on the date of the first visit where response was lost. Subjects who discontinued the study without having lost response will be censored on the date of discontinuation (i.e. date of last visit performed).
| days | Certolizumab Pegol 400 mg |
|---|---|
| Time to Loss of Response After Baseline of Study C87042 (NCT00308581) on Subjects Who Were in Clinical Response at Baseline of This Study | 169.5 ± 274.1 |
The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Results are presented as the percentage of subjects with at least 1 hospital stay during the treatment period.
| percentage of participants | Certolizumab Pegol 400 mg |
|---|---|
| Occurrence of at Least 1 Hospital Stay During the Treatment Period | 21.4 ± 0.730 |
Follow-up period starts the day after the last injection up to 84 days after last injection. Results are presented as the percentage of subjects with at least 1 hospital stay during the follow-up period.
| percentage of participants | Certolizumab Pegol 400 mg |
|---|---|
| Occurrence of at Least 1 Hospital Stay During the Follow-Up Period | 21.8 ± 0.578 |
Overall period corresponds to both treatment and follow-up periods in C87046. Results are presented as the percentage of subjects with at least 1 hospital stay during the overall period.
| percentage of participants | Certolizumab Pegol 400 mg |
|---|---|
| Occurrence of at Least 1 Hospital Stay During the During the Overall Period | 37.6 ± 0.953 |
The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.
| days | Certolizumab Pegol 400 mg |
|---|---|
| Length of Hospital Stays During the Treatment Period | 1.838 ± 5.785 |
Follow-up period starts the day after the last injection up to 84 days after last injection.
| days | Certolizumab Pegol 400 mg |
|---|---|
| Length of Hospital Stays During the Follow-Up Period | 2.782 ± 7.743 |
Overall period corresponds to both treatment and follow-up periods in C87046.
| days | Certolizumab Pegol 400 mg |
|---|---|
| Length of Hospital Stays During the Overall Period | 4.620 ± 9.704 |
The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Results are presented as the percentage of subjects with at least 1 emergency room visit during the treatment period.
| percentage of participants | Certolizumab Pegol 400 mg |
|---|---|
| Occurrence of at Least 1 Emergency Room Visit During the Treatment Period | 13.1 ± 0.413 |
Follow-up period starts the day after the last injection up to 84 days after last injection. Results are presented as the percentage of subjects with at least 1 emergency room visit during the follow-up period.
| percentage of participants | Certolizumab Pegol 400 mg |
|---|---|
| Occurrence of at Least 1 Emergency Room Visit During the Follow-Up Period | 6.1 ± 0.265 |
Overall period corresponds to both treatment and follow-up periods in C87046. Results are presented as the percentage of subjects with at least 1 emergency room visit during the overall period.
| percentage of participants | Certolizumab Pegol 400 mg |
|---|---|
| Occurrence of at Least 1 Emergency Room Visit During the Overall Period | 19.2 ± 0.471 |
The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics. Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the treatment period.
| percentage of participants | Certolizumab Pegol 400 mg |
|---|---|
| Anti tumor necrosis factor (Anti-TNF) | 0.4 ± 0.066 |
| Immunosuppressants | 3.9 ± 0.195 |
| Corticosteroids | 24.0 ± 0.733 |
| 5- Aminosalicylic Acid (5-ASA) | 5.2 ± 0.356 |
| Antibiotics | 55.5 ± 2.889 |
Follow-up period start the day after the last injection up to 84 days after last injection. Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics. Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the follow-up period.
| percentage of participants | Certolizumab Pegol 400 mg |
|---|---|
| Anti tumor necrosis factor (Anti-TNF) | 16.2 ± 0.702 |
| Immunosuppresants | 5.2 ± 0.250 |
| Corticosteroids | 15.3 ± 0.622 |
| 5- Aminosalicylic Acid (5-ASA) | 2.2 ± 0.185 |
| Antibiotics | 14.0 ± 0.829 |
Overall period corresponds to both treatment and follow-up periods in C87046. Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics. Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the overall period.
| percentage of participants | Certolizumab Pegol 400 mg |
|---|---|
| Anti tumor necrosis factor (Anti-TNF) | 16.2 ± 0.716 |
| Immunosuppressants | 8.3 ± 0.337 |
| Corticosteroids | 35.4 ± 0.986 |
| 5- Aminosalicylic Acid (5-ASA) | 7.0 ± 0.408 |
| Antibiotics | 62.4 ± 2.974 |
The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Results are presented as the number of subjects who used at least 1 concomitant medication during the treatment period.
| participants | Certolizumab Pegol 400 mg |
|---|---|
| Occurrence of at Least 1 General Concomitant Medication During the Treatment Period | 185 ± 10.172 |
Follow-up period start the day after the last injection up to 84 days after last injection. Results are presented as the number of subjects who used at least 1 concomitant medication during the follow-up period.
| participants | Certolizumab Pegol 400 mg |
|---|---|
| Occurrence of at Least 1 General Concomitant Medication During the Follow-Up Period | 71 ± 3.395 |
Overall period corresponds to both treatment and follow-up periods in C87046. Results are presented as the number of subjects who used at least 1 concomitant medication during the overall period.
| participants | Certolizumab Pegol 400 mg |
|---|---|
| Occurrence of at Least 1 General Concomitant Medication During the Overall Period | 195 ± 10.948 |
The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the treatment period.
| participants | Certolizumab Pegol 400 mg |
|---|---|
| Occurrence of at Least 1 Concurrent Medical Procedure During the Treatment Period. | 148 ± 4.656 |
Follow-up period start the day after the last injection up to 84 days after last injection. Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the follow-up period.
| participants | Certolizumab Pegol 400 mg |
|---|---|
| Occurrence of at Least 1 Concurrent Medical Procedure During the Follow-Up Period | 84 |
Overall period corresponds to both treatment and follow-up periods in C87046. Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the overall period.
| participants | Certolizumab Pegol 400 mg |
|---|---|
| Occurrence of at Least 1 Concurrent Medical Procedure During the Overall Period | 173 |
Collected over Maximum of 166 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Certolizumab Pegol 400 mg | — | 73/229 (31.9%) | 190/229 (83%) |
| Event | Certolizumab Pegol 400 mg |
|---|---|
| Crohn's diseaseGastrointestinal disorders | 22/229 |
| Colonic stenosisGastrointestinal disorders | 5/229 |
| Abdominal abscessInfections and infestations | 5/229 |
| Perianal abscessInfections and infestations | 5/229 |
| Abdominal painGastrointestinal disorders | 4/229 |
| Chest painGeneral disorders | 3/229 |
| Anal fistulaGastrointestinal disorders | 2/229 |
| Intestinal obstructionGastrointestinal disorders | 2/229 |
| Intestinal stenosisGastrointestinal disorders | 2/229 |
| Small intestinal obstructionGastrointestinal disorders | 2/229 |
| Event | Certolizumab Pegol 400 mg |
|---|---|
| NasopharyngitisInfections and infestations | 63/229 |
| PyrexiaGeneral disorders | 47/229 |
| HeadacheNervous system disorders | 47/229 |
| Abdominal painGastrointestinal disorders | 45/229 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 44/229 |
| Crohn's diseaseGastrointestinal disorders | 41/229 |
| DiarrhoeaGastrointestinal disorders | 33/229 |
| InfluenzaInfections and infestations | 30/229 |
| CoughRespiratory, thoracic and mediastinal disorders | 28/229 |
| Back painMusculoskeletal and connective tissue disorders | 27/229 |
| Age, Categorical(Participants) | Certolizumab Pegol 400 mg |
|---|---|
| <=18 years | 1 |
| Between 18 and 65 years | 224 |
| >=65 years | 4 |
| Age, Continuous(years) | Certolizumab Pegol 400 mg |
|---|---|
| Mean | 31.8 ± 11.6 |
| Sex: Female, Male(Participants) | Certolizumab Pegol 400 mg |
|---|---|
| Female | 146 |
| Male | 83 |
| Region of Enrollment(participants) | Certolizumab Pegol 400 mg |
|---|---|
| France | 20 |
| United States | 70 |
| Canada | 20 |
| Spain | 6 |
| Belgium | 30 |
| Austria | 8 |
| Netherlands | 2 |
| Germany | 34 |
| United Kingdom | 9 |
| Switzerland | 4 |
| Italy | 24 |
| Sweden | 2 |
This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.
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